RecruitingNot ApplicableNCT05708261

Tailoring Healthy Relationships to Improve HIV Outcomes

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

Sponsor

Arizona State University

Enrollment

120 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

HIV

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria37

Aim 1 MSM
years of age or older
MSM by self-report
HIV-positive status confirmed by HIV self-test
Sub-optimal ART adherence confirmed by Visual Analog Scale
Live in Eastern Cape confirmed by map exercise
Mentally competent to provide voluntary informed consent
Prescribed ART
Own a smartphone for personal use
Comfortable talking about living with HIV and relationships in group settings
In 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 partner
Partner status is unknown or HIV-negative
Health Professional and Technical Experts
Provide 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 Africa
Mentally competent to provide voluntary informed consent
Community Advisory Board
Identifies as MSM
In a relationship with a man
Participates in HIV-related activities focused on MSM
years of age (N=4) or 26 years of age and older (N=4)
Lives in Eastern Cape
Aim 2 MSM (only)
years of age or older
MSM by self-report
HIV-positive status confirmed by HIV self-test
Sub-optimal ART adherence confirmed by Visual Analog Scale
Live in Eastern Cape confirmed by map exercise
Mentally competent to provide voluntary informed consent
Prescribed ART
Own a smartphone for personal use
Comfortable talking about living with HIV and relationships in group settings
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.
Have not disclosed HIV-positive status to partner
Partner HIV-status is unknown or HIV-negative

Exclusion Criteria37

Aim 1 MSM
Under 18 years of age
Is not MSM by self-report
Is not HIV-positive as confirmed by HIV self-test
Does not have sub-optimal ART adherence confirmed by Visual Analog Scale
Does not live in Eastern Cape confirmed by map exercise
Is not mentally competent to provide voluntary informed consent
Not prescribed ART
Does not own a smartphone for personal use
Is not comfortable talking about living with HIV and relationships in group settings
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.
Has disclosed their HIV-positive status to partner
Partner is HIV-positive
Health Professional and Technical Experts
Does 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 Africa
Not mentally competent to provide voluntary informed consent
Community Advisory Board
Does not identify as MSM
Is not in a relationship with a man
Does not participate in HIV-related activities focused on MSM
Is not 18-25 years of age (N=4) or 26 years of age and older (N=4)
Does not live in Eastern Cape
Aim 2 MSM (only)
Under 18 years of age
Is not MSM by self-report
Is not HIV-positive as confirmed by HIV self-test
Does not have sub-optimal ART adherence confirmed by Visual Analog Scale
Does not live in Eastern Cape confirmed by map exercise
Is not mentally competent to provide voluntary informed consent
Not prescribed ART
Does not own a smartphone for personal use
Is not comfortable talking about living with HIV and relationships in group settings
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.
Has disclosed their HIV-positive status to partner
Partner is HIV-positive

Interventions

BEHAVIORALMR 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.

OTHERBe 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.

Locations(1)

Foundation for Professional Development

East London, South Africa

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