Impact of an Analytical Treatment Interruption on Partners and Family Members of Trial Participants in Durban, South Africa: A Qualitative Study

Krista Dong¹Mzwakhe Wiseman Ngcobo²Ntombifuthi Langa²Ayanda Zulu²Luyanda Maphalala³Vanessa Pillay³Maud Mthembu⁴Whitney Tran⁵Rachel Lau⁵Annie Miall¹Deborah Mindry⁶Ali Ahmed⁵Thumbi Ndung'u⁷Karine Dube^8*

• ¹Ragon Institute of Mass General MIT and Harvard, Cambridge, United States
• ²Integration of TB in Education and Care for HIV/AIDS (ITEACH), Pietermaritzburg, South Africa
• ³Females Rising through Education, Support and Health (FRESH), Durban, South Africa
• ⁴University of KwaZulu-Natal, Durban, South Africa
• ⁵University of California San Diego, La Jolla, United States
• ⁶University of California Global Health Institute, San Francisco, United States
• ⁷Africa Health Research Institute, Durban, South Africa
• ⁸University of California, San Diego, La Jolla, United States

Background HIV cure-related research often include analytical treatment interruptions (ATIs), which are monitored pauses in antiretroviral therapy (ART) to determine whether interventions can stimulate viral control without ART. While ATIs have been conducted in high-income countries, scale-up in low-income HIV high-burden countries in sub-Saharan Africa raise unique ethical, social, and practical challenges. HIV cure-related trials focus on participants without considering the experiences of partners and family members. Here, we explore the perspectives of partners and family members, including their emotional, relational, and mental health, during an ATI-inclusive HIV cure trial conducted in Durban, South Africa. Methods We conducted a qualitative socio-behavioral study to explore the experiences of close contacts of ATI trial participants. Between November 2022 and June 2024, we interviewed partners and family members referred by trial participants. Interviews explored understanding of the trial, emotional and relational impacts, and concerns about ATIs. The interviews were conducted in English and/or isiZulu, transcribed, translated, and analyzed using content analysis to identify themes related to partner protections, trial communication, and psychosocial support. Results Ten participants comprised five male partners (two living with HIV, three without) and five female family members (two mothers, two sisters, one cousin). Most had limited knowledge of HIV cure research but expressed hope for its advancements alongside concerns about ART discontinuation and viral rebound. Partners without HIV valued pre-exposure prophylaxis (PrEP) but reported inconsistent use, while partners with HIV feared re-infection during viral rebound. Mothers expressed concerns about ATIs, while sisters sought clearer information. Participants recommended improved communication, partner protections and psychosocial support, while acknowledging the trial's scientific importance. Conclusions ATI-inclusive HIV cure trials affect participants and their close social networks comprised of family members and intimate partners. Ethical trials are responsible for ensuring the safety of participants and other impacted groups. Family and partners were a critical source of support for trial participants, but have been underutilized in ATI-inclusive trials. Leveraging this existing support network in future ATI trials may improve safety while facilitating recruitment, willingness to discontinue ART during ATIs, prevent early ATI discontinuation, support adherence to frequent visits and sampling requirements, improving overall trial success.