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NCT05708261
Tailoring Healthy Relationships to Improve HIV Outcomes
Conditions: HIV
Sex: Male
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Arizona State University
Location: South Africa
Summary
This study will adapt the evidence-based intervention, Healthy Relationships, and then assess its feasibility using a pilot randomized controlled trial with HIV-positive MSM living with HIV in Eastern Cape, South Africa
Eligibility Criteria
INCLUSION CRITERIA:Aim 1 MSM18 years of age or olderMSM by self-reportHIV-positive status confirmed by HIV self-testSub-optimal ART adherence confirmed by Visual Analog ScaleLive in Eastern Cape confirmed by map exerciseMentally competent to provide voluntary informed consentPrescribed ARTOwn a smartphone for personal useComfortable talking about living with HIV and relationships in group settingsIn a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others.Have not disclosed HIV-positive status to partnerPartner status is unknown or HIV-negativeHealth Professional and Technical ExpertsProvide clinical care (medical or nursing) to MSM in Eastern Cape, South Africa (Health Professionals only)Experience developing mobile technologies for HIV prevention and treatment in Eastern Cape, South Africa (Technical Experts only)Live in Eastern Cape, South AfricaMentally competent to provide voluntary informed consentCommunity Advisory BoardIdentifies as MSMIn a relationship with a manParticipates in HIV-related activities focused on MSM18-25 years of age (N=4) or 26 years of age and older (N=4)Lives in Eastern CapeAim 2 MSM (only)18 years of age or olderMSM by self-reportHIV-positive status confirmed by HIV self-testSub-optimal ART adherence confirmed by Visual Analog ScaleLive in Eastern Cape confirmed by map exerciseMentally competent to provide voluntary informed consentPrescribed ARTOwn a smartphone for personal useComfortable talking about living with HIV and relationships in group settingsIn a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others and the relationship is more than 1 month old.Have not disclosed HIV-positive status to partnerPartner HIV-status is unknown or HIV-negativeEXCLUSION CRITERIA:Aim 1 MSMUnder 18 years of ageIs not MSM by self-reportIs not HIV-positive as confirmed by HIV self-testDoes not have sub-optimal ART adherence confirmed by Visual Analog ScaleDoes not live in Eastern Cape confirmed by map exerciseIs not mentally competent to provide voluntary informed consentNot prescribed ARTDoes not own a smartphone for personal useIs not comfortable talking about living with HIV and relationships in group settingsNot in a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others or in this defined relationship for less than a month.Has disclosed their HIV-positive status to partnerPartner is HIV-positiveHealth Professional and Technical ExpertsDoes not provide clinical care (medical or nursing) to MSM in Eastern Cape, South Africa (Health Professionals only)No experience developing mobile technologies for HIV prevention and treatment in South Africa (Technical Experts only)Does not live in Eastern Cape, South AfricaNot mentally competent to provide voluntary informed consentCommunity Advisory BoardDoes not identify as MSMIs not in a relationship with a manDoes not participate in HIV-related activities focused on MSMIs not 18-25 years of age (N=4) or 26 years of age and older (N=4)Does not live in Eastern CapeAim 2 MSM (only)Under 18 years of ageIs not MSM by self-reportIs not HIV-positive as confirmed by HIV self-testDoes not have sub-optimal ART adherence confirmed by Visual Analog ScaleDoes not live in Eastern Cape confirmed by map exerciseIs not mentally competent to provide voluntary informed consentNot prescribed ARTDoes not own a smartphone for personal useIs not comfortable talking about living with HIV and relationships in group settingsNot in a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others, or in this defined relationship for less than a month.Has disclosed their HIV-positive status to partnerPartner is HIV-positive
Source: ClinicalTrials.gov (NCT05708261). StuddyBuddy aggregates publicly available trial information.