Improving HIV outcomes through tailored relationship interventions
Tailoring Healthy Relationships to Improve HIV Outcomes for MSM in Eastern Cape, South Africa
NA · Arizona State University · NCT05708261
This study is testing a new online program to help HIV-positive men who have sex with men in South Africa improve their relationships and better manage their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Arizona State University (other) |
| Locations | 1 site (East London) |
| Trial ID | NCT05708261 on ClinicalTrials.gov |
What this trial studies
This project adapts the Healthy Relationships intervention to create a new program called MPowered in Relationships (MR) for HIV-positive men who have sex with men (MSM) in Eastern Cape, South Africa. The intervention focuses on enhancing skills related to HIV stress assessment, communication for disclosure, and safe sex practices. It will be delivered via Zoom, including group check-ins to reinforce learned skills and assess individual action plans. The study aims to evaluate the feasibility, acceptability, and potential impact of the intervention on ART adherence and viral load among participants.
Who should consider this trial
Good fit: Ideal candidates are HIV-positive MSM aged 18 and older living in Eastern Cape who have sub-optimal ART adherence and are comfortable discussing their HIV status in group settings.
Not a fit: Patients who are not MSM, do not live in Eastern Cape, or have optimal ART adherence may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve ART adherence and health outcomes for HIV-positive MSM.
How similar studies have performed: Similar interventions have shown promise in improving health outcomes for MSM, but this specific adaptation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
East London
- Foundation for Professional Development — East London, South Africa (RECRUITING)
Study contacts
- Study coordinator: Debra Fisher
- Email: debra.fisher@asu.edu
- Phone: 602-496-0931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV