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Table 3 Summary of findings and preliminary considerations for planning ATI trials with racial, ethnic, sex and gender diverse HIV serodifferent partners

From: “It comes altogether as one:” perceptions of analytical treatment interruptions and partner protections among racial, ethnic, sex and gender diverse HIV serodifferent couples in the United States

• It will be important to give PWH decision tools to make informed decisions around emerging HIV control options – including possible risks, benefits, and trade-offs. More emphasis should be dedicated to understanding unmet needs for PWH and their partners in the search towards an HIV cure.

• There are mixed understandings of U = U in the community, even among HIV serodifferent partners. Planning ATI trials should occur concurrently with increased community engagement around treatment as prevention messages. Research teams should support PWH disclose loss of HIV undetectable status to their partners.

• In the community, ATIs may be perceived as contradicting ART adherence messages and as a breach of U = U. The scientific rationale for ATIs used in HIV cure trials should be carefully communicated in lay terms. ATIs may cause worries and discomforts around passing or acquiring HIV, particularly among HIV serodifferent partners (and also secondary partners).

• ATIs have several implications for both participants and partners – including the need for frequent viral load measurements, robust partner protection measures, good communication, and disclosure plans for both primary and secondary partners. Institutional review boards (IRBs) may consider asking ATI research teams to include risk mitigation plans as part of operations manuals.

• Our study showed strong support for PrEP provision (and/or referral) during ATIs. ATI trials should be implemented jointly with efforts to increase PrEP awareness and access in the community. Research teams should emphasize the element of choice (e.g., daily PrEP, on-demand PrEP), and increase HIV prevention options available during ATI trials.

• If possible, research teams should offer (peer) counseling and social support for both partners. Robust strength-based interventions emphasizing resilience should also be developed to help couples through ATIs.

• For the most part, partners without HIV would like to be engaged in the ATI research process (even though they would not be considered ATI trial participants). Partners’ wishes should be respected with regards to their involvement in the research process. Dyads may represent critical units of analysis and interventions in the context of ATI trials.