Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection

Обзор

This randomized controlled trial evaluates the efficacy of couples HIV testing and counseling retesting. Eligible couples previously enrolled in NCT05000866 are invited to participate. Those who do are randomized to either couples HIV testing and counseling (CHTC) retesting or an individual HIV testing control. Follow-ups occur 3 and 6 months post intervention.

Подробное описание

The purpose of this study is to evaluate the benefits associated with couples HIV testing and counseling (CHTC) resting. After their 12-month follow-up, those participants who remain in the same relationship they were in at the time of their baseline will be offered the opportunity to continue in the components proposed in this revision. Those who consent will be randomized to either complete a second session of CHTC or to a comparison condition in which both partners receive a routine individual HIV test. HIV positive partners in serodiscordant couples randomized to the control condition will receive information about anti-retroviral treatment adherence and U=U (undetectable = untransmissible). Given potential attrition and rates of relationship dissolution, we anticipate randomizing 200 couples (80% of the original sample). Follow-up assessments will be conducted 3 and 6 months after retesting (15 and 18 months after the participants' original baseline appointment).

Вмешательства

• Поведенческое Couples HIV testing and counseling
  Couples HIV testing follows a CDC published protocol for delivery of HIV testing to relationship partners. HIV test results are obtained from Oraquick (FDA approved for at home HIV testing)
• Поведенческое Individual HIV testing and counseling
  Individual HIV testing and counseling uses a counseling protocol based on the standard of care for routine HIV pre- and post-test counseling. HIV test results are obtained from Oraquick (FDA approved for at home testing)

Первичные конечные точки

• number of condomless anal sex acts with a casual partner in the absence of PrEP [Срок оценки: 6 months]

Вторичные конечные точки (4)

• Binge drinking [Срок оценки: 6 months]
• pre-exposure prophylaxis (PrEP) uptake [Срок оценки: 6 months]
• PrEP adherence [Срок оценки: 6 months]
• Drug use Frequency [Срок оценки: 6 months]

Критерии участия

Inclusion:

• enrolled previously in the parent study DA050508 (NCT05000866).
• in a relationship with the same main partner with whom they completed the baseline intervention session.
• both partners in the couple must consent to continue with activities specified in this revision.
• completion of the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision.

Exclusion: any of the following at the 12-month follow-up:

• serious psychiatric symptoms;
• current suicidal/homicidal ideation;
• gross cognitive impairment
• a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• University of Michigan — Ann Arbor
• Hunter College — New York

Публикации

• Starks TJ, Kyre K, Castiblanco J, Parker JN, Kahle E, Stephenson R, Cain D. Comparing Repeated (Annual) Couples HIV Testing and Counseling to Individual HIV Testing and Counseling Among Male Couples at High Risk of HIV Infection: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2024 Feb 13;13:e53023. doi: 10.2196/53023. PMID 38349737

Идентификаторы

NCT: NCT05833074 · R01 DA050508-S1 · R01DA050508-03S1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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