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RECRUITING

NCT05708261

Tailoring Healthy Relationships to Improve HIV Outcomes

Sponsor: Arizona State University

View on ClinicalTrials.gov

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

Official title: Tailoring Healthy Relationships to Improve HIV Outcomes for MSM in Eastern Cape, South Africa

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-10-01

Completion Date

2024-10-29

Last Updated

2024-04-03

Healthy Volunteers

Conditions

HIV

Interventions

BEHAVIORAL

MR Intervention

Grounded in Social Cognitive Theory, the intervention delivers five 2-hour sessions with 3 post-session group check-in's to develop skills in partnership communication, HIV disclosure and prevention. The intervention utilizes self-assessments on skills learned and then action plan for these developed and then finalized in the last session.

OTHER

Be Well Attention Match

Attention match control arm providing one-way SMS of general health content delivered once per week during the first 5 weeks after enrollment.

INCLUSION CRITERIA: Aim 1 MSM 1. 18 years of age or older 2. MSM by self-report 3. HIV-positive status confirmed by HIV self-test 4. Sub-optimal ART adherence confirmed by Visual Analog Scale 5. Live in Eastern Cape confirmed by map exercise 6. Mentally competent to provide voluntary informed consent 7. Prescribed ART 8. Own a smartphone for personal use 9. Comfortable talking about living with HIV and relationships in group settings 10. In a relationship with a man (defined as a boyfriend, partner, husband, lover) with whom they are emotionally and romantically connected to all others. 11. Have not disclosed HIV-positive status to partner 12. Partner status is unknown or HIV-negative Health Professional and Technical Experts 1. Provide clinical care (medical or nursing) to MSM in Eastern Cape, South Africa (Health Professionals only) 2. Experience developing mobile technologies for HIV prevention and treatment in Eastern Cape, South Africa (Technical Experts only) 3. Live in Eastern Cape, South Africa 4. Mentally competent to provide voluntary informed consent Community Advisory Board 1. Identifies as MSM 2. In a relationship with a man 3. Participates in HIV-related activities focused on MSM 4. 18-25 years of age (N=4) or 26 years of age and older (N=4) 5. Lives in Eastern Cape Aim 2 MSM (only) 1. 18 years of age or older 2. MSM by self-report 3. HIV-positive status confirmed by HIV self-test 4. Sub-optimal ART adherence confirmed by Visual Analog Scale 5. Live in Eastern Cape confirmed by map exercise 6. Mentally competent to provide voluntary informed consent 7. Prescribed ART 8. Own a smartphone for personal use 9. Comfortable talking about living with HIV and relationships in group settings 10. In 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. 11. Have not disclosed HIV-positive status to partner 12. Partner HIV-status is unknown or HIV-negative EXCLUSION CRITERIA: Aim 1 MSM 1. Under 18 years of age 2. Is not MSM by self-report 3. Is not HIV-positive as confirmed by HIV self-test 4. Does not have sub-optimal ART adherence confirmed by Visual Analog Scale 5. Does not live in Eastern Cape confirmed by map exercise 6. Is not mentally competent to provide voluntary informed consent 7. Not prescribed ART 8. Does not own a smartphone for personal use 9. Is not comfortable talking about living with HIV and relationships in group settings 10. Not 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. 11. Has disclosed their HIV-positive status to partner 12. Partner is HIV-positive Health Professional and Technical Experts 1. Does not provide clinical care (medical or nursing) to MSM in Eastern Cape, South Africa (Health Professionals only) 2. No experience developing mobile technologies for HIV prevention and treatment in South Africa (Technical Experts only) 3. Does not live in Eastern Cape, South Africa 4. Not mentally competent to provide voluntary informed consent Community Advisory Board 1. Does not identify as MSM 2. Is not in a relationship with a man 3. Does not participate in HIV-related activities focused on MSM 4. Is not 18-25 years of age (N=4) or 26 years of age and older (N=4) 5. Does not live in Eastern Cape Aim 2 MSM (only) 1. Under 18 years of age 2. Is not MSM by self-report 3. Is not HIV-positive as confirmed by HIV self-test 4. Does not have sub-optimal ART adherence confirmed by Visual Analog Scale 5. Does not live in Eastern Cape confirmed by map exercise 6. Is not mentally competent to provide voluntary informed consent 7. Not prescribed ART 8. Does not own a smartphone for personal use 9. Is not comfortable talking about living with HIV and relationships in group settings 10. Not 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. 11. Has disclosed their HIV-positive status to partner 12. Partner is HIV-positive

Locations (1)

Foundation for Professional Development

East London, South Africa