Tailoring Healthy Relationships to Improve HIV Outcomes

NCT05708261 | Recruiting

• 1 other identifier: STUDY00014539
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HIV

Outcome Measures

Primary Outcomes (4)

• Feasibility Survey

  A study specific survey to assess feasibility, willingness, safety, acceptability

  Month 3

• Feasibility Survey

  A study specific survey to assess feasibility, willingness, safety, acceptability

  Month 6

• Feasibility Interview

  Indepth interview to assess feasibility, willingness, safety, acceptability

  Month 3

• Feasibility Interview

  Indepth interview to assess feasibility, willingness, safety, acceptability

  Month 6

Secondary Outcomes (4)

• HIV viral load

  Month 0

• HIV viral load

  Month 9

• HIV treatment adherence

  Month 0

• HIV treatment adherence

  Month 9

Study Arms (2)

MR Intervention

EXPERIMENTAL

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.

Behavioral: MR Intervention

Be Well

OTHER

Attention match control arm. Participants will receive standard of care for HIV treatment and one-way SMS with video content about general health. This will occur once per week during the first 5 weeks after enrollment.

Other: Be Well Attention Match

Interventions

MR Intervention BEHAVIORAL

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.

MR Intervention

Be Well Attention Match OTHER

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

Be Well

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arizona State University: lead
• Foundation for Professional Development: collaborator

Study Sites (1)

Foundation for Professional Development

East London, South Africa

RECRUITING

Central Study Contacts

Debra Fisher

CONTACT

602-496-0931; debra.fisher@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a behavioral intervention designed to provide HIV communication and disclosure skill building to improve treatment adherence.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: February 1, 2023
• Study Start: October 1, 2022
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

ZA (1)