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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03483857

Enrollment

103

Registered

2018-03-30

Start date

2017-09-21

Completion date

2018-06-29

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Keywords

Peer Navigation

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.

Interventions

BEHAVIORALPeer Navigation

Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Two arm study assessing to determine feasibility and acceptability of a pilot PN intervention among 100 HIV-positive MSM. We will explore associations between PN participation and continuum of care outcomes in a cohort of 55 HIV-positive MSM receiving PN, as compared to a cohort of 48 HIV-positive MSM receiving standard-of-care clinical referral, in preparation for a full-scale multi-site behavioral efficacy trial.

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026