Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa

Not Applicable

Completed

• Conditions: Hiv
• Interventions: Behavioral: Peer Navigation

• Registration Number: NCT03483857
• Lead Sponsor: University of California, San Francisco

Brief Summary

This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been implemented among HIV-positive men and women in the general population in North West province, South Africa, by members of this research team.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 103

Inclusion Criteria

• Biological male;
• Age >=18 years;
• Self-identify as a gay or bisexual man, or a transgender woman;
• Have male sexual partners within the prior six months
• Resident in the Ehlanzeni District Municipality for at least six months of the year;
• Be physically present in Ehlanzeni for at least two weeks per month
• Self-disclosed receiving an HIV-positive diagnosis in the last 5 years;
• Consent to all serological testing for HIV antibodies, ART analytes, and HIV RNA
• Consent for study staff to review participants' clinical records;
• Consent to the randomization process.

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Exclusion Criteria

• Inability to provide written informed consent for participation, including being under the influence of alcohol or drugs.
• Inability to provide laboratory or documentary evidence of HIV diagnosis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Navigation	Peer Navigation	Individuals assigned to the PN condition will be assigned to one of 10 PN case managers who will follow an SOP described for initial intake and follow up visits with each participant. Participants will be asked to provide contact information for themselves and up to 3 individuals whom study staff can contact in case they cannot make direct contact with the study participant assigned to PN. PN will meet with their clients at least once monthly to discuss treatment related issues including medication access, side effects, adherence, stigma or discrimination related to HIV or their taking ART medication, etc. Participants will have contact information for their assigned PN and may contact them for reasons related to their treatment between scheduled monthly visits if they choose. All visits with PN will be recorded by the PN. and participants who fail to attend up to 3 scheduled PN appointments will be considered LTFU for the intervention.

Primary Outcome Measures

Name	Time	Method
Viral Suppression	6 months	The proportion of participants virally suppressed (HIV RNA \<1000 copies/microliter) in Peer Navigation (Intervention) arm compared to standard of care (SOC) arm.

Trial Locations

Locations (1)

Anova Health Institute; 🇿🇦 Nelspruit, Mpumalanga, South Africa