Developing a pilot lifestyle intervention to prevent cardiovascular disease in midlife women with HIV

Abstract

Background

Background: Women with HIV (WWH) are at elevated risk for cardiovascular disease (CVD) compared to men with HIV. Lifestyle interventions, like the Diabetes Prevention Program (DPP), may reduce CVD risk, but most fail to address barriers to healthy behaviors facing WWH.

Objective

Objective: To inform the adaptation of the DPP for midlife WWH, pilot the modified intervention, and assess feasibility, acceptability, and implementation barriers.

Methods

Methods: Interviews were conducted with cisgender, English-speaking WWH ages 40–59 to assess intervention preferences. The adapted DPP was piloted and evaluated. CVD knowledge, CVD risk perception, quality of life, and physical activity were assessed pre- and post-intervention.

Results

Results: Eighteen WWH completed interviews. Adaptations included reducing the number of sessions and adding HIV, CVD, stress, aging, menopause, and smoking content. Of 14 women contacted for the pilot, seven completed a baseline, five attended group sessions, and five completed a post-treatment assessment. Attendance barriers included transportation access and costs. Satisfaction was moderate; informal exit interviews indicated that women would recommend the program. CVD knowledge, perceived risk, and physical activity increased, and fatigue and mental health improved. Content on nutrition, aging, HIV, and stress was seen as most useful; suggested changes included group exercises and additional content on recipes, HIV management, and aging.

Conclusions

Conclusions: Midlife WWH reported benefits from our adapted intervention. Increases in CVD knowledge and perceived CVD risk suggest improved awareness of the impact of lifestyle behaviors. Retention was adequate; socioeconomic barriers were common. Intervention feasibility and acceptability may be improved via remote access and further content customization.

Keywords:

• Women
• HIV
• cardiovascular disease
• lifestyle intervention

Introduction

Advances in antiretroviral therapy (ART) in recent decades have contributed to decreased HIV-related mortality rates and enabled persons with HIV (PWH) to live a lifespan more similar to non-HIV-infected individuals than ever before.^1,2 The number of PWH in midlife and older will continue to grow as this population ages, and as new HIV diagnoses are experienced among adults over 40. Indeed, individuals in the United States (U.S.) between the ages of 40 and 59 accounted for 55% of PWH in 2016, compared to 17% in 1996.^3,4 In 2017, women ages 45 to 54 accounted for 20% of new diagnoses among women.⁵

As individuals with HIV live longer, they face greater risk for age-associated chronic diseases, including cardiovascular disease (CVD).⁶ PWH are twice as likely to develop CVD than the general population.⁷ Reasons for this observed increase in CVD mortality may be attributed to use of select antiretroviral medications,^8,9 chronic inflammation,¹⁰ and higher rates of smoking, dyslipidemia, and insulin resistance^11–13 relative to people without HIV, though the exact mechanisms remain unclear. CVD risk is especially acute for women with HIV (WWH), who have a 50 percent greater relative risk for incident CVD compared to HIV-seropositive men.^12,14 Potential reasons for this inflated risk profile include: the influence of menopause¹⁵; underuse of CVD treatments, screening, and therapeutic interventions compared to men^16,17; and greater accumulation of abdominal visceral fat compared to women without HIV.^18,19 However, while the link between HIV and heightened CVD risk is well-established among PWH,^7,20–23 women remain grossly underrepresented in both CVD²⁴ and HIV research.^25,26

Lifestyle modification interventions emphasizing weight loss and increased physical activity have successfully improved traditional modifiable CVD risk factors (e.g. systolic blood pressure, waist-to-hip ratio) in PWH,^27–29 and WWH specifically.³⁰ A systematic review of physical activity interventions among PWH found that regular aerobic exercise, both alone and in combination with resistance training, can significantly improve body composition and cardiorespiratory status.²⁹ However, most lifestyle interventions are resource-intensive (e.g. supervised exercise³⁰ or individualized sessions),³¹ and therefore unlikely to be sustainable long-term. Many programs also fail to incorporate behaviors critical to CVD prevention (e.g. smoking cessation), thus failing to optimize potential clinical benefit to participants.

Further, few interventions have utilized “gold standard” approaches to lifestyle modification among PWH. From 1996 to 2001, a national observational study known as the Diabetes Prevention Program (DPP) tested a lifestyle intervention against pharmacological therapy among adults at risk for type 2 diabetes.³² While both treatments were effective, the lifestyle intervention reduced type 2 diabetes incidence by nearly two-fold, and was associated with reduced CVD risk after three years.^33,34 Two known studies have tested the impact of the DPP on cardiometabolic markers of CVD among individuals with HIV. Fitch and colleagues³¹ found improvements in systolic blood pressure and waist circumference among participants who received DPP-informed individual sessions over the course of six months.³¹ Another study comparing the effects of metformin and a DPP-inspired lifestyle modification program on atherosclerotic indices among individuals with HIV found significant improvements in some metabolic parameters and cardiorespiratory fitness in the DPP group.³⁵ Unfortunately, the generalizability of findings from both studies is limited by underrepresentation of women in the participant samples.

Despite the apparent benefits of lifestyle modification in reducing CVD risk factors, few WWH regularly engage in heart health behaviors (e.g. regular aerobic activity, diet limited in saturated fat and cholesterol, avoidance of tobacco). Data published in 2016 show that just 48% of WWH in the U.S. reported any physical activity of moderate intensity in the past week.³⁶ A 2017 meta-analysis found that 55% of WWH in the U.S. were current smokers,³⁷ compared to 12% among the general public.³⁸ Focus group discussions with this population have helped identify a number of barriers to exercise in particular, including physical health problems, lack of motivation or self-efficacy, and low social support.³⁹ Moreover, preliminary self-report data among older women (ages 45 and above) with HIV reveal a perceived inability to control their health and inadequate knowledge of physical activity and dietary guidelines,⁴⁰ in addition to higher rates of depression compared to men with HIV.⁴¹ Other challenges for aging WWH may stem from menopausal symptoms¹⁵ and a broader lack of awareness of CVD risk,¹³ particularly among subgroups with lower average health literacy.⁴²

These data collectively suggest a need for lifestyle modification programs tailored to aging WWH in order to maximize potential health benefits. However, current clinical guidelines for HIV patients with (or at risk for) CVD stipulate generic counseling and/or medication management, and fail to emphasize the increased HIV-associated cardiovascular risk among women compared to men.^43,44 Several studies, including prior data collected by our research group, have demonstrated that older WWH prefer interventions designed specifically to address their unique needs.^42,45 Few studies to date have explicitly explored the barriers to engagement in heart health behaviors in this population, or employed gold standard lifestyle modification tailored to aging WWH for the purpose of CVD prevention. Thus, the aim of this two-part investigation was to: (1) adapt the DPP to the needs of midlife WWH, and (2) pilot the modified DPP intervention in midlife WWH, assessing feasibility, acceptability, and perceived barriers to implementation.

Materials & methods

Participants & recruitment

In Phase I of this study, WWH in midlife were purposively sampled to participate in individual, semi-structured qualitative interviews. Participants were recruited from the Boston metropolitan area using flyers and through brief presentations at community organizations serving clients with HIV. Inclusion criteria included: (1) HIV diagnosis; (2) cisgender women; (3) age 40–59 years; (4) English-speaking; and (5) able to provide informed consent. Participants were excluded from the study if: (1) unwilling to be audiotaped; or (2) otherwise unsuitable for participation (e.g. severe untreated psychiatric illness). Recruitment strategies, as well as inclusion and exclusion criteria, were identical for Phase II of this study.

Procedures & measures

Phase I

Phone screens were conducted by research assistants to determine eligibility, and eligible participants attended a single study visit, where informed consent was obtained. Participants completed an individual qualitative interview exploring perceived CVD risk, current heart health behaviors, barriers and facilitators to heart health behaviors, and interest in and preferences for a lifestyle modification program. Interviews were digitally recorded and conducted with either the principal investigator or research assistant. Following the conclusion of the interviews, the DPP was modified based on these qualitative data and according to the ADAPT-ITT⁴⁶ framework for developing evidence-based HIV interventions. Institutional Review Board (IRB) approval was obtained prior to study initiation and participants were compensated for their participation. All Phase I procedures were conducted between November 2017 and June 2018.

Qualitative interviews

A semi-structured, open-ended interview guide was developed based on an extensive literature review and input from study team members. Interview questions were open-ended to avoid biasing participant responses, and were followed by probes to facilitate discussion. The interview guide drew on the Health Belief Model, which explicates engagement in health behaviors based on perceived vulnerability to and severity of health problems, benefits and barriers to action, and self-efficacy.⁴⁷ Thus, questions probed participants’ perceived vulnerability to and risk for heart disease, personal challenges to engaging in heart health behaviors, and sense of control over their health. Interviews covered a range of topics including perceived CVD risk, heart health behaviors, and a variety of potential barriers and facilitators to engaging in such behaviors (data not reported here). This manuscript focuses on participants’ interest in and preferences for a CVD-focused lifestyle intervention for aging WWH. In particular, participants were asked to comment on the content, format, duration, and location of their ideal program. Sample interview questions and probes are provided in Table 1.

Table 1 Phase I qualitative interview content areas & questions/probes

Content area	Sample questions & probes
Interest in future program	We are conducting these interviews to better understand your experience so that we can tailor our program based on the needs of midlife women with HIV. Would you be interested in participating in a program like this? (If no: Why not?)
Preferences for future program	What types of topics would you like to see? What would be helpful to you personally to better manage your health and prevent cardiovascular disease? How much of the intervention content should focus on stressors related specifically to HIV? Aging/menopause? What would be the ideal format for this program? For instance: Group-based or individual? Why? How many meetings? How long would each meeting be? When and where?

Sample content areas, questions, and probes from qualitative interviews conducted in Phase I.

Sociodemographic questionnaires

Participants also self-reported sociodemographic information (e.g. age, race, ethnicity, education level, employment status, income, sexual orientation, relationship status, date of HIV diagnosis, smoking status, menopause status).

Phase II

Women (n = 7) who chose to participate in Phase II, the open pilot phase, attended a baseline assessment visit where they provided informed consent and completed a quantitative assessment. They then participated in the adapted DPP lifestyle intervention, referred to as the Developing a Strong Heart in HIV (DASHH) Program, over the course of eight weeks. The pilot intervention was conducted in a group format and covered topics related to nutrition, exercise, and behavioral self-management, specifically as they concern WWH in midlife. All participants were provided with a program binder containing session handouts, as well as a copy of “The CalorieKing Calorie, Fat & Carbohydrate Counter” book.⁴⁸ Those who completed the intervention (n = 5) attended a post-treatment assessment visit, where they again completed self-report quantitative measures and participated in an informal (unrecorded) qualitative exit interview to discuss their experiences in the study. IRB approval was obtained prior to initiation of the open pilot. All participants were compensated. All Phase II procedures were conducted between June and October 2018.

Quantitative assessments and sociodemographic questionnaires

At the baseline visit, prior to participating in the adapted intervention, participants self-reported sociodemographic data (e.g. age, race, ethnicity, education level, employment status, income, sexual orientation, relationship status, date of HIV diagnosis, smoking status, menopause status). At both the baseline and post-treatment assessments, participants also completed: the 25-item Heart Disease Fact Questionnaire (HDFQ)⁴⁹; the 20-item Perception of Risk of Heart Disease Scale (PRHDS)⁵⁰; the 20-item AIDS Clinical Trials Group Multidimensional Health Status Assessment (ACTG QOL-602)⁵¹; and the 7-item International Physical Activity Questionnaire Short Form (IPAQ-SF).⁵² Of note, due to limited resources, no biological data (e.g. blood pressure) were collected for analysis at any time during this study.

Feasibility and acceptability of DASHH pilot intervention

Feasibility of the adapted intervention was assessed by tracking the proportion of approached participants who enrolled, and the number of group sessions and assessments attended by enrolled participants. Reasons for declining enrollment or prematurely leaving the study were also recorded. Acceptability was assessed using the eight-item Client Satisfaction Questionnaire (CSQ-8),⁵³ as well as through questions during informal qualitative exit interviews that were designed to explore acceptability of the pilot intervention. Interviews were not formally analyzed as digital recordings were not available. Sample interview questions and probes are provided in Table 2.

Table 2 Phase II informal exit interview content areas & questions/probes

Content area	Sample questions & probes
Overall study experience	How was your overall experience in the group?
Helpfulness of session content	Which topics were most relevant / useful? Why? Which topics were least relevant / useful? Why?
Suggested improvements to program	What topics do you wish had been covered that were not? How could the program be improved?
Likelihood of recommending program	Would you recommend this program to someone else? Why or why not?

Sample content areas, questions, and probes from informal exit interviews conducted in Phase II.

Analyses

Phase I

Phase I qualitative interviews were digitally recorded and transcribed, and transcripts were analyzed using content analysis.^54,55 Prior to analysis, three members of the study team independently reviewed the transcripts to generate an overarching thematic framework and identify themes for interpretation. Coding was facilitated by NVivo software version 12,⁵⁶ and performed by three independent coders. Validity and reliability of coding results were ensured through consensus meetings, in which coders reviewed and compared findings, and discrepancies in coding were resolved. Coders also maintained an audit trail of coding schemes and NVivo files throughout the process. Descriptive statistics were calculated for sociodemographic variables.

Phase II

Quantitative data were stored and managed using the Research Electronic Data Capture (REDCap) system.⁵⁷ Descriptive statistics were calculated, though small sample sizes precluded formal significance testing. Participants completed individual, informal exit interviews (i.e. not audio recorded) to provide general descriptive feedback on the intervention.

Results

Eighteen participants completed in-depth qualitative interviews in Phase I; of these participants, seven enrolled in the pilot intervention in Phase II (38.9%). Sociodemographic data for all participants across both study phases are presented in Table 3.

Table 3 Participant demographic characteristics

Variable	Phase I (N = 18)		Phase II (N = 7)
	M (SD)		M (SD)
Age (in years)	49.1 (5.5)		48.9 (4.0)
Years since HIV diagnosis	Not collected		19.5 (6.5)
	n	%	n	%
Race
Black/African American	10	55.6	6	85.7
White	6	33.3	1	14.3
More than one race	1	5.6	–	–
Unknown or unreported race	1	5.6	–	–
Ethnicity
Hispanic or Latina	2	11.1	–	–
Not Hispanic or Latina	14	77.8	7	100
Unknown or unreported ethnicity	2	11.1	–	–
Education
Less than high school degree	4	22.2	1	14.3
High school graduate/GED	5	27.8	1	14.3
Some college or college graduate	8	44.4	5	71.4
Some graduate education	1	5.6	–	–
Employment
On disability	14	77.8	6	85.7
Full-time	3	16.7	1	14.3
Part-time	1	5.5	–	–
Income
$10,000 or less	12	66.7	3	42.8
$10,001 to $20,000	2	11.1	–	–
$20,001 to $40,000	3	16.7	2	28.6
$40,001 to $60,000	–	–	1	14.3
$60,001 to $80,000	1	5.5	–	–
Other/prefer not to answer	–	–	1	14.3
Sexual orientation
Exclusively heterosexual	15	83.3	6	85.7
Heterosexual with some homosexual experience	2	11.1	1	14.3
Bisexual	1	5.6	–	–
Relationship status
Single	8	44.4	4	57.1
In committed relationship or domestic partnership	2	11.1	–	–
Married	3	16.7	1	14.3
Separated or divorced	4	22.2	1	14.3
Widowed	1	5.6	1	14.3
Smoking status
Current	6	33.3	–	–
Former	4	22.2	3	42.9
Never	8	44.5	4	57.1
Menopause status
Post-menopausal	8*	44.4	1	14.3

* Data from two participants were invalid and therefore not included.

Percentages may not total 100 due to rounding.

Sociodemographic information collected via quantitative self-report in Phase I and Phase II.

Phase I: qualitative interviews

Individual qualitative interviews conducted during Phase I informed our adaptation of the DPP lifestyle intervention for midlife WWH. Our coding efforts revealed five main categories of interest for the program, including desire for: (1) content around issues related to HIV, (2) content around aging and menopause, (3) general content around heart health and CVD prevention, (4) nutritional and exercise-related information, and (5) content around mental health and wellness. With respect to other general goals for the program, participants shared their preferences regarding logistics and expressed a desire to connect with other women, improve their self-esteem, and engage in group physical activity.

Desire for content around issues related to living with HIV

Participants expressed interest in discussing issues related to living with HIV, including exercise and nutrition in the context of HIV, the link between HIV and cardiovascular health, and other health conditions. Several women mentioned concerns about cardiovascular side effects of HIV medications, and expressed desire for more information regarding medication-related issues, though participants were largely unaware of the correlation between HIV and CVD. Additional suggested topics included aging among WWH, as well as discussions around HIV stigma, relationships, and HIV disclosure, especially with potential sexual partners.

… What would women in my age group do, if we find out that the medicine that we're on to help suppress the disease, keep it undetectable, it's damaging our heart, what do we do. You know, do we tell the doctor no, I'm not taking it anymore? And is there an alternative medicine that can still provide what we need, but not damage it any more than what is already damaged because we've been on that particular medicine for ten years… You know we can't reverse what's already happened, but we can stop it from getting worse. (54 years old)

Now that they have this harm reduction situation, you know, it’s like people with HIV has… been pushed in the back. You know what I’m saying? And we still need support, you know. Even if I’m a long term survivor, I still need my peers… Because I’m getting older with it, you know? With HIV. I want to know about my body. I want to know if there’s preventive measures that I can take that’s going to prolong my life. (52 years old)

Desire for content around aging and menopause

Participants demonstrated a dearth of knowledge about menopause, both in the context of HIV and in general. They specifically requested more educational information, including detail on common menopause symptoms such as hot flashes, night sweats, bladder control problems, and sleeplessness. A few participants stated that all intervention content should be tailored for women experiencing menopause, while others felt that it should be more HIV-focused.

I think general information [about menopause]. And if there’s any difference between, like, regular menopause and women with HIV and menopause… if there is a difference, I think that would [be] information we’d like to have and know. (50 years old)

I know women that have actually had menopause in their thirties, so learning more about it and what you can do to ease it, because that could be very stressful as well. Yeah, that would really help. (40 years old)

I know absolutely nothing about menopause or hot flashes that I get… Yes, that [menopause-related content] would be very helpful, since I’m at that age where everybody is going through menopause. (55 years old)

Desire for content on heart health and CVD prevention (unrelated to HIV)

Nearly all participants expressed a desire for basic education around cardiovascular health. They requested information about a variety of topics related to CVD prevention, including smoking, weight loss, nutrition, blood pressure management, and diabetes management.

I would like to talk about what happens to your heart after you stop smoking. Like, you know, the damage that probably was done. So like what are your stages internal, what does it go through now? I would like to know about that. (42 years old)

Learning more about how to lose weight and keep weight so that way your heart can be healthy. Good carbs from bad carbs, learning the difference between the two. Less strenuous exercises. Knowing what the best exercises are for a better heart, basically. (40 years old)

You can even have some demonstration, exercises that you can do… A film that shows the effects of the heart… Or maybe some speaker coming and talking… a heart doctor telling the importance of the heart. And then… somebody… from the gym [to] help you all to do some exercise that [is] not tremendous, but, you know, start doing things at the home. Fun things. (49 years old)

Desire for general nutrition and exercise content, as well as related group activities

Participants reported an interest in nutritional information, including education around heart-healthy foods, recipes, and distinctions between “good” and “bad” fats and carbohydrates. Several women requested healthful substitution ideas that could be incorporated into existing cultural or familial favorites. One participant raised the idea of a cooking class, during which the women could implement their new nutritional knowledge and taste-test healthy recipes. Women also expressed a desire for information around weight loss and weight maintenance, as well as exercise tips for those unable to access a gym facility or other fitness activities. Several participants stated an interest in incorporating group physical activities, such as walking or stationary biking, into the program.

Well, how much exercise we should do to reach our goals. Like when you set your goal… to losing 50 pounds, you want support on how to cook more healthy meals, without having to have fried food all the time. Like you know sometimes, you go to support groups… most of the time they have pizza. Or fried chicken, or whatever. (59 years old)

If you were to have some kind of way to find out things that were going on that were community based, that was free to join or maybe five dollars or something… to pay for an exercise session, that would, you know, help to get people out and going to something they could do. You know, making us aware of what was happening in the community, physically, or even if there was something food-related… that would help with our heart health. If you were to let us know so that we could be a part of it, that would be great. (50 years old)

Desire for content around mental health and wellness

Participants proposed a variety of topics around mental health and wellness, both related to HIV and cardiovascular health. Topics of interest included stress management techniques, relaxation exercises, and discussions around coping with everyday stress. A few women specifically cited meditation as a skill they hoped to learn through the program, and one that they believed would help them manage stress and mental health issues, such as depression. Additionally, participants expressed a desire for discussions around staying motivated and maintaining a positive mindset, particularly in relation to living with HIV as a woman in midlife.

A lot of people think about death more than they think about life… And they need to think about life, and… how to live with this. Because a lot of people live with it. And being motivated… to do things that make your mind more appreciative of yourself, and to say, you know, hey, this has happened to me, and it’s a negative aspect. But once you motivate yourself and you keep healthy, you feel better. Because you don’t have to die from HIV. (49 years old)

Like, before, I’ve had friends that died with AIDS; they didn’t live very long. This is before the protease inhibitors came out. You know, like, now, we’re living very long, long lives. So, why not even more? Go a little step further, as to what are we doing to maintain these healthy lives… Coping, dealing, and healing. What makes us who we are. (52 years old)

So, that all plays a part of your heart. If you're not happy… I don't know, just the stress, I talked about the stress. Meditation. (48 years old)

Relationships… because that has something to do with heart disease as well, because it’s like, stress causes heart attacks… Like unhealthy relationships… Any kind of relationships. (40 years old)

Other goals for the program

Developing relationships with other group members was a frequently cited goal of participation in the program. Participants reported a desire to connect with other women confronting similar challenges, and to learn from one another’s experiences. One woman expressed a desire to improve her self-esteem in the context of living with HIV through her participation in the group.

I just think that if it's group, then you could bounce things off of each other, support each other, give each other ideas… And as a way of teaching each other… we can share things and knowing it's not just between you and one person, but that you have other ones, other people around you that are like you. (54 years old)

It would help… us develop relationships, you know? And if you want to take it further, you know, we could have a group outside the group. You know, and get together, go to Dunkin Donuts, to the movies. (52 years old)

And I guess for me would be anyone like me, of how can we figure out to help ourselves physically, mentally, nutrition-wise, on feeling better about ourselves and not thinking less of us, ourselves, because we have the virus… And I guess willing to let other people in our inner circle, to be a support, be a friend, or anything else. And that maybe we can support each other within that program that you have, and that maybe we'd be willing to support each other outside of that program. You know, willing to share phone numbers, meet up with each other, so we can be a support, not just within that period of time of that group. (54 years old)

Preference for small group over individual format

In general, participants reported a preference for a group format, rather than individual, though some suggested a combination of the two. Many women stressed the importance of a group dynamic conducive to sharing freely and supporting one another, and small group size emerged as a common preference. One participant expressed a desire for a group facilitator who also has HIV, who might be better able to relate to the challenges faced by group participants.

If you're in a group setting, learning the importance of not being nonjudgmental, knowing that you can set some ground rules about what's talked about in a group stays in a group. (54 years old)

I think when [the group] gets too large, the sense of community can get a bit lost… People are unable to share. And… it just can become voyeuristic. (50 years old)

Suggestions for program length and session duration

When asked about their ideal group session length, most participants preferred one to two hours per session. Some women had no preference regarding program duration; others expressed preferences ranging from eight weeks, to six months, to ongoing indefinitely. One participant stressed that the program should last as long as a person would need support.

Phase II: adaptation of DPP intervention for midlife WWH

Based on our formative qualitative interviews in Phase I, we tailored the existing Diabetes Prevention Program (DPP) intervention manual to meet the needs of midlife WWH for pilot testing in Phase II. The DPP was modified using the ADAPT-ITT⁴⁶ framework for evidence-based HIV intervention development, which includes numerous phases beginning with a needs and preferences assessment of the target population, followed by material adaptation and intervention piloting.

Qualitative data from Phase I suggested that few participants were aware of the link between HIV and CVD, though most had spoken to their medical providers about heart health more generally. With respect to heart health behaviors, most reported current attempts to “eat healthy” and exercise, with a high degree of variability in knowledge and approach to implementation. Physical and mental health problems, lack of access and/or prohibitive cost (of exercise facilities, healthy food, etc.), stress, and stigma were commonly cited barriers to engagement in healthy lifestyle behaviors. Conversely, facilitators to these behaviors included self-motivation, public programs and resources, spirituality, and support from HIV groups, providers, and family members. These data will be reported in greater detail in a separate manuscript exploring perspectives on cardiovascular health among midlife WWH.

Table 4 outlines the revisions applied to existing DPP content based on the qualitative themes and intervention preferences that emerged from our Phase I interviews. Key modifications included: adding content on CVD, adding a module on smoking cessation, and incorporating content on psychosocial challenges specific to women aging with HIV. Additionally, in order to produce a scalable intervention, the number of weekly sessions was reduced from 16 to eight, and the content condensed by retaining only material critical and relevant to the target population.

Table 4 Phase I qualitative themes & changes to diabetes prevention program (DPP)

Themes from Phase I qualitative interviews	Existing DPP content	Changes to DPP based on Phase I qualitative themes
Lack of knowledge about link between HIV and heart health	None	Added basic education on HIV as risk factor for CVD
Lack of motivation as a barrier to healthy behaviors	Plans for maintaining motivation for behavior change; recovering from a slip; reviewing progress	No change
Physical health problems as a barrier to healthy behaviors	None	Added information on pain, fatigue as barriers to physical activity
Personal stress as a barrier to healthy behaviors	Stress and diabetes; preventing and managing stress/stressors	Added information on stress as a link between HIV and CVD
Mental health problems as barrier to healthy behaviors	Managing negative thought patterns; positive self-talk	No change
Stigma as a barrier to healthy behaviors	None	Added discussion of impact of stigma on mood, and effects on healthy behaviors
Social support as a facilitator of healthy behaviors	Increasing support/helpful social cues; social support as a motivation strategy	No change
Desire for healthy eating strategies and recommendations	Recommended levels of fat consumption; food shopping tips; weighing/measuring food; the calorie equation	Simplified information; less emphasis on calories and more emphasis on balanced diet
Desire for exercise resources and recommendations	Setting activity goals; tips on increasing and tracking daily activity; F.I.T.T. principles	Added community resources
Desire for information about smoking and CVD	None	Added module on smoking cessation, including basic education and local resources
Desire for information about aging with HIV; menopause	None	Added module on impact of menopause on stress, well-being, and CVD risk

Themes from qualitative interviews conducted in Phase I, relevant pre-existing Diabetes Prevention Program (DPP) content, and changes to DPP content based on themes from Phase I interviews..

The main goals of the adapted intervention were to provide information around: (1) the links between HIV, CVD, and being female; (2) heart-healthy nutrition; (3) physical activity for cardiovascular health; and (4) effective stress management. Specifically, the adapted group sessions included an orientation to the program goals and overview of CVD basics (Welcome to the DASHH Program), information and recommendations related to nutrition and physical activity (Calories and Fat; Being Active and MyPlate), tips for eating out and changing food habits (Lifestyle Cues and Eating Out), confronting negative thoughts and managing HIV over time (Our Thoughts and Aging Well with HIV), techniques for preventing and managing stress (Managing Stress), an overview of HIV and smoking, including resources for quitting (Aerobic Fitness and Smoking), and strategies for maintaining healthy habits in the long term (Overview and Staying Motivated). Group physical activities were not incorporated into the program for logistical and liability-related reasons.

Phase II: quantitative assessments

Participants who completed the intervention (n = 5) showed increases in CVD knowledge (HDFQ; 60.8 vs. 66.4) and CVD risk perception (PRHDS; 52.8 vs. 56) at post-treatment. Women also reported categorical improvements in overall physical activity (IPAQ-SF) following the intervention; four out of five women reported increased activity. In terms of health-related quality of life, participants reported improvements in physical pain (ACTG QOL-602; 62.2 vs. 73.3), fatigue (46 vs. 56), physical functioning (65 vs. 70), and mental health (46.6 vs. 51.9).

Phase II: feasibility and acceptability of DASHH pilot intervention

Feasibility

Of the eighteen participants that participated in Phase I, 14 expressed interest in and were contacted for Phase II. Of those 14 women, seven completed a baseline (50%), five attended group sessions (71.4%), and five completed a post-treatment assessment (71.4%). Reasons for non-participation included scheduling conflicts, family stressors, and medical problems. Among the five group participants, average attendance was six out of eight group sessions (range: 2 to 7). Four women (80%) attended six or more sessions. Attendance barriers included transportation costs and access, and family medical issues.

Acceptability

Satisfaction with the adapted intervention was moderate; mean CSQ-8 score was 16 out of 32 (n = 5; SD = 5.8). Four participants stated that they were “mostly satisfied” or “very satisfied” (80%), and four stated that they would recommend the program to a friend (80%). Qualitative data from the informal exit interviews suggested that participants enjoyed being in a group of women, and appreciated the opportunity to speak openly about their experiences. Participants were generally satisfied with program logistics, including the timing, duration, and location of group sessions, though one cited her visual impairment as a barrier to using public transportation to travel to sessions. Several participants enjoyed the small group size, describing it as more “intimate,” and expressed appreciation for the individual who facilitated the group.

Session content related to nutrition, aging with HIV, and stress was identified as most useful, while information on environmental factors of healthy living (e.g. triggers for healthy eating and/or being physically active), eating out, aerobic fitness, and smoking were viewed as least useful. Suggested improvements to the program included more content and discussion around HIV management, healthy recipes, and successful aging, both in general and in the context of living with HIV. Several participants also expressed a desire for group stretching or relaxation exercises at the beginning or end of each session.

Discussion

In this study, we adapted a nationally recognized lifestyle intervention, the Diabetes Prevention Program (DPP), to the needs of aging women with HIV (WWH) using qualitative interview data, and piloted the intervention (DASHH Program) in a small sample of midlife WWH. The DASHH Program was intended to emphasize heart health, as WWH bear greater risk for CVD compared to women without HIV.^7,14 Further, our data suggested limited knowledge of the correlation between HIV and CVD, thus justifying a special focus on heart health behaviors throughout the program. While recruitment and retention were challenging, the intervention was successfully conducted using minimal resources (i.e. money, time, personnel), and was acceptable to participants who, on the whole, expressed satisfaction with their experience. To our knowledge, this is the first study to develop a CVD prevention and lifestyle modification program for midlife WWH.

Qualitative interview data from Phase I participants suggested an almost universal desire for support in maintaining a healthy lifestyle in the context of HIV, and a desire to connect with other WWH of a similar age. These sentiments are echoed in the published literature^42,45,58 and supported the group-based format used for our intervention. In a qualitative study by Gakumo et al. (2015), African American WWH over age 50 reported a preference for health literacy interventions that were team-based, simple, and specifically tailored to their individual needs and level of health education.⁴² When surveyed on their preferences for intervention content, participants in the present study expressed interest in topics spanning five themes: (1) challenges related to living with HIV; (2) aging and menopause; (3) heart health and CVD prevention; (4) nutrition and physical exercise; and (5) mental health and wellness in the context of HIV (and other life stressors). Participants also emphasized a desire for support managing mental health challenges and coping with everyday problems related (and not related) to HIV, such as stigma. Indeed, published data show high rates of depression and social isolation, and lower quality of life among PWH,^59–61 and prior research has identified a need for resources and support related to HIV stigma and loneliness among older WWH,⁶² both of which have been associated with increased depression in PWH.⁶³

Also consistent with the extant literature – which has documented lower levels of menopause awareness in WWH compared to women without HIV, as well as a misattribution of menopause symptoms to HIV itself in this population^60,64–66 – our qualitative data reveal poor knowledge about menopause, including the connection between menopause and CVD, among the midlife WWH sampled in our study. Fortunately, participants acknowledged this educational gap and expressed a desire to learn about the common physical manifestations of menopause (e.g. hot flashes), in addition to health behaviors critical for preventing CVD (e.g. diabetes and blood pressure management). Phase I participants also identified multiple barriers to heart health behaviors, including a general lack of financial and other resources, physical limitations, and poor mental health, all of which have been identified by PWH in other studies involving lifestyle interventions⁶⁷; these issues were specifically addressed and discussed during DASHH Program group sessions.

The finalized DASHH Program (i.e. Phase II open pilot) reflected these qualitative findings (modifications are summarized in Table 4). DPP material was also modified to de-emphasize weight loss and diabetes management, given the nature of our target population and, instead, to emphasize heart health and well-being in the context of living with HIV. We also reduced the number of group sessions from 16 to eight (lasting 60–75 minutes each) in an effort to maximize intervention scalability, and in light of stated scheduling conflicts and transportation challenges reported by the WWH who participated in the pilot.

Quantitative data and informal qualitative feedback collected from DASHH Program participants at the post-treatment assessment suggested perceived benefit from participation and good intervention acceptability. Compared to baseline, participants at post-treatment self-reported increases in knowledge of CVD, perceived personal risk for developing CVD, and physical activity, and improvements in several domains of physical and mental health. While we were unable to conduct significance testing due to the small sample size, these results are nonetheless encouraging. Interestingly, participants noted benefiting most from content related to nutrition, aging with HIV, and stress management – not CVD content, as suggested by quantitative data – which suggests that, while participants demonstrated positive improvements in CVD knowledge, they seem to have cared most about other content areas, including those more relevant to HIV. These findings are consistent with other studies of older WWH that have highlighted the importance of coping with HIV-related stressors, eating well, and eliminating sources of negativity in order to live “well” while aging with HIV.⁶⁸ Participants especially valued the intimate group setting, which offered ample opportunities to connect with other WWH facing similar aging and health-related challenges. Most women reported moderate to high satisfaction with their experience, and most noted that they would recommend the program.

Intervention feasibility, including rates of enrollment, retention, and session attendance, was mixed, as less than half of Phase I participants elected to participate in the Phase II pilot intervention. Attendance and retention rates in Phase II, however, were high; five of seven (71.4%) enrolled participants attended group sessions (i.e. 28.6% attrition), and most (80%) of active participants attended six or more sessions. Common reported barriers to participation (including barriers to group session attendance) were scheduling conflicts, life stressors, medical problems or illness, and transportation issues, which was consistent with prior research on engagement in lifestyle interventions involving PWH.⁶⁷ From a financial and resource perspective, costs of the intervention were limited to participant compensation (up to $135 across both phases) and time dedicated to recruitment and group sessions. While the pilot group meetings were administered by a doctoral-level psychologist, Master’s level professionals, research assistants, and community members may be successfully trained to lead sessions, further minimizing cost. Indeed, one participant raised the possibility of a “referral” program, whereby prior participants would serve as “coaches” to new participants, which is consistent with previous studies documenting both the desire for, and utility of, peer-led interventions among WWH across a range of content areas, including self-care behaviors, self-esteem, social support, and HIV symptom management.^69–71

There were several limitations in this study. Statistical power and generalizability of the study findings were limited by the small sample size and the fact that all women were recruited from the same health centers and community organizations in the greater Boston area. Thus, our findings may have limited application to WWH in other geographic locations. Additionally, we were not able to formally analyze the informal qualitative exit interviews conducted following the pilot intervention in Phase II, as digital recordings were not available. With regard to measuring physical activity, some IPAQ data were missing or incomplete as participants appeared to struggle with the measure; however, categorical increases in overall physical activity were observed for the majority of participants. Further, this study did not incorporate real-time data from physical activity trackers, such as Fitbits, to confirm self-reported increases in physical activity from pre- to post-intervention. Finally, due to limited resources and a short timeline that disallowed long-term follow-up, we were unable to collect biological data or track CVD outcomes among our participants.

Despite these limitations, the present study contributes important insights to the literature on the preferences of WWH for a lifestyle modification program adapted to their unique needs, as well as the feasibility, acceptability, and implementation barriers of such a program. Though recruitment and retention posed challenges, the pilot intervention was conducted with limited financial burden, thus enhancing potential scalability. Future studies should test this adapted CVD prevention and lifestyle modification program in a larger sample of older WWH. Intervention feasibility and acceptability may be improved by offering remote access to group sessions (e.g. via phone, internet, or digital social platform), utilizing peer leaders for group sessions, and further customizing content around successful aging for WWH. Moreover, biological markers of CVD risk, such as blood pressure, may prove useful, in addition to tracking cardiovascular health outcomes and real-time physical activity data to verify self-reported health behavior changes.

Acknowledgments

We would like to acknowledge the efforts of our participants, and thank them for participating in the open pilot and for sharing their experiences with us.

Disclosure statement

The authors report no conflict of interest.

Additional information

Funding

This work was supported by the Harvard University Center for AIDS Research Scholar Award (Parent Award: National Institute of Allergy and Infectious Diseases) under Grant 5P30AI060354-14. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Notes on contributors

Greer Raggio

Greer Raggio, PhD, MPH is a Behavioral Psychologist at the National Center for Weight and Wellness in Washington, D.C., with expertise in behavioral weight management and bariatrics. She was formerly a Clinical Research Fellow in the Behavioral Medicine Program within the Department of Psychiatry at Massachusetts General Hospital in Boston, MA.

Georgia Goodman

Georgia Goodman, BS is a Senior Clinical Research Coordinator in the Behavioral Medicine Program within the Department of Psychiatry at Massachusetts General Hospital, and a Project Coordinator in the Behavioral Science Research Program at The Fenway Institute in Boston, MA.

Gregory K. Robbins

Gregory K. Robbins, MD is a physician in the Division of Infectious Disease at Massachusetts General Hospital, and an Associate Professor of Medicine at Harvard Medical School in Boston, MA.

Sara E. Looby

Sara E. Looby, PhD, ANP-BC is a researcher in the Yvonne L. Munn Center for Nursing Research and the Metabolism Unit at Massachusetts General Hospital, and an Assistant Professor of Medicine at Harvard Medical School in Boston, MA.

Allison Labbe

Allison Labbe, PhD is a clinical psychologist in the Behavioral Medicine Program within the Department of Psychiatry at Massachusetts General Hospital, and an Instructor in Psychology at Harvard Medical School in Boston, MA.

Christina Psaros

Christina Psaros, PhD is the Associate Director of the Behavioral Medicine Program within the Department of Psychiatry at Massachusetts General Hospital, and an Associate Professor of Psychology at Harvard Medical School in Boston, MA.