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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483857
• Other study ID #: 1R34MH109395-01
• Status: Completed
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: June 29, 2018

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hiv
• HIV Seropositivity

Intervention

Behavioral:
• Peer Navigation
Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.

Locations

Country	Name	City	State
South Africa	Anova Health Institute	Nelspruit	Mpumalanga

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	ANOVA Health Institute, National Institutes of Health (NIH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Suppression	The proportion of participants virally suppressed (HIV RNA <1000 copies/microliter) in Peer Navigation (Intervention) arm compared to standard of care (SOC) arm.	6 months