Ethical and practical considerations for mitigating risks to sexual partners during analytical treatment interruptions in HIV cure-related research

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Table 1. IRB-Approved Interview guide: Ethical and practical considerations for mitigating risks to sexual partners during ATIs in HIV cure-related research.

Introduction First, thank you so much for your time. Can you please describe your involvement in HIV-related research?

Considerations for ATI Participants What should research teams do during the informed consent process of ATI study participants? Do you think ATI study participants should disclose their HIV status to their sexual partners? What types of support should be provided to participants who want to disclose their status to their partner(s)? Do you think ATI study participants should disclose their participation to their sexual partners? What if their partner is HIV-negative? What should research teams do if study participants do not want to inform their sexual partners? What if their partner is HIV-negative? What materials should be developed to help ATI study participants navigate the ATI process? What should research teams do if ATI study participants have new sexually transmitted infections (STIs) (STIs may indicate unprotected sexual intercourse during ATIs)?

Considerations for Sexual Partners of ATI Study Participants Do you think research teams should refer sexual partners of ATI study participants to receive PrEP (particularly if they are HIV-negative)? Do you think partners should be asked to come to the study site to receive information? Do you think partners should be asked to complete an informed consent process? What should research teams do in case of multiple and/or anonymous partners? What materials should be developed to support sexual partners of ATI study participants?

Table 2. Demographic characteristics of key informant interview participants.

Participant Number	Sex	Race/Ethnicity	Informant Type
01	Male	White/Caucasian	Biomedical researcher*
02	Male	White/Caucasian	Biomedical researcher
03	Male	White/Caucasian	Bioethicist
04	Female	Black/African American	Community member
05	Female	Black/African American	Socio-behavioral researcher/epidemiologist
06	Male	White/Caucasian	Community member
07	Female	Black/African American	Community member
08	Female	White/Caucasian	Biomedical researcher
09	Male	Black/African American	Community member
10	Male	White/Caucasian	Biomedical researcher
11	Male	White/Caucasian	Biomedical researcher*
12	Male	White/Caucasian	Community member
13	Male	White/Hispanic	Community member
14	Male	White/Caucasian	Socio-behavioral researcher/epidemiologist
15	Female	Black/African American	Community member
16	Male	Black/African American	Community member
17	Female	White/Caucasian	Community member
18	Female	White/Caucasian	HIV care provider
19	Female	White/Caucasian	Bioethicist
20	Female	White/Caucasian	Biomedical researcher
21	Female	Black/African American	Socio-behavioral researcher/epidemiologist

* Biomedical researchers with active HIV care responsibilities. For this study, they were interviewed as biomedical researchers.

Table 3. Summary of possible ethical and practical considerations for mitigating risks to sexual partners during ATIs in HIV cure-related research (United States, 2020).

Considerations for ATI Participants Informed consent information around risk of HIV transmission to sexual partners during ATIs should remain as clear as possible. Different modalities can be employed for different communities, including women and racial and ethnic minorities to increase participant understanding of informed consent materials such as companion pieces and consent videos. An assessment of understanding is recommended. There should be adequate community involvement around the design of informed consent strategies. Disclosure of HIV status to sexual partners should be encouraged, but not be mandated or enforced. Attention should be paid to cultural aspects and relationship dynamics around HIV disclosure. Research teams should support ATI trial participants, through counseling, the provision of negotiation skills and/or disclosure scripts, etc., should they wish to disclose. Disclosure of ATI research participation to sexual partners should be encouraged but not be required. However, research teams should support participants through the disclosure process, particularly in cases of HIV sero-different relationships, unprotected sex with HIV-negative partners, and when U = U is relied upon as the HIV prevention method. There should be sensitivity to relationship dynamics, as well as social, psychological, and cultural issues around disclosure. In complex situations where there is no ATI disclosure and risk of onward transmission, there should be counseling on risks of HIV/STI transmission to partners, dialogue, education and mental health support. Situations should be reviewed on a case-by-case basis and attention paid to complex relationships dynamics and social/sexual networks. Participants should be made aware of local laws around HIV/STI transmission. Research teams should consider developing materials to simplify ATI information and clearly explain the need for partner protection. These can include documents to accompany the informed consent process, videos, presentations, fact sheets, websites, and role plays, among others that are appropriate for all affected communities. Materials should help empower participants around possible trade-offs and could also be used with HIV care providers or in community engagement efforts. In cases of incident STIs during ATI trials, participants should be referred for prompt treatment, counseling, and contact tracing. Research teams must carefully consider whether discontinuing participants would be too punitive and engage communities to determine the best way to deal with incident STIs in different contexts. More consensus should be generated in the community on how to deal with incident STIs during ATI trials.

Considerations for Sexual Partners of ATI Study Participants To the extent possible, HIV-negative sexual partners of ATI study participants should be referred to receive PrEP. More deliberative work will be needed to define the role of daily PrEP versus on-demand PrEP in the context of ATI trials. In addition to PrEP, other HIV prevention options should be discussed, such as external or internal condoms, dapivirine vaginal rings for female partners, voluntary medical male circumcision, etc. There should be more in-depth discussion and careful navigation in situations involving multiple and anonymous partners. More caution should be exercised when ATI trial participants disclose having multiple and/or anonymous sexual partners. More consensus should be generated in the community on how to deal with multiple and/or anonymous sexual partners during ATIs. Careful attention should also be paid to socio-cultural dynamics where PrEP availability, accessibility, acceptability, and/or uptake may be lower. Partners should be invited to come to the research sites to receive additional counseling if needed, although this should not be mandatory. Research teams can explore innovative ways to engage partners, such as telehealth visits. Robust standards of risk mitigation measures should be in place with all partners. Research teams should acknowledge people’s lived experiences and foster prevention altruism^31 among ATI trial participants. All parties involved should recognize unintended secondary HIV transmission events may considerably set back the field of HIV cure-related research. Research teams should consider developing materials for partners of ATI trial participants that explain possible risks of the study and mitigation strategies which are appropriate for all affected communities. These could include slides, frequently asked questions, videos, flowcharts, letters, vignettes, scenarios, scripts, handouts, etc. Ultimately, partner protection should be about building relationships, trust, and good communication. Research teams and/or networks may consider developing partner protection guidelines before initiating ATI trials (e.g., plans and/or standard operating procedures) and updating them as needed.

O'Dell BL, Rosser BRS, Miner MH, Jacoby SM. HIV prevention altruism and sexual risk behavior in HIV-positive men who have sex with men. AIDS Behav. 2008;12(5):713–720.

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