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

Primary Purpose

Hiv

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Peer Navigation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hiv focused on measuring Peer Navigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Anova Health Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer Navigation

Standard of Care

Arm Description

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.

Individuals assigned to SOC will be referred directly to the NCHC/RLS staff for treatment initiation or continuation. At intake they will receive standard treatment information per MPDOH guidelines, as well as information about Anova's RLS and Health4Men clinical and psychosocial services available at the NCHC. They will receive monthly text message reminders from study staff to refill ART prescriptions, and a separate reminder in month 6 to schedule complete their 6-month clinical visit. Study staff will verify that participants have picked up medications and attended all scheduled clinical visits by means of chart review and data extraction. Per MPDOH guidelines, individuals who fail to collect medications 3 months in a row, or who fail to attend their 6-month HIV clinical follow-up appointment, will be considered non-engaged and lost to follow up (LTFU).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2017
Last Updated
February 3, 2020
Sponsor
University of California, San Francisco
Collaborators
ANOVA Health Institute, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03483857
Brief Title
Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
Official Title
Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
ANOVA Health Institute, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv
Keywords
Peer Navigation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Navigation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Individuals assigned to SOC will be referred directly to the NCHC/RLS staff for treatment initiation or continuation. At intake they will receive standard treatment information per MPDOH guidelines, as well as information about Anova's RLS and Health4Men clinical and psychosocial services available at the NCHC. They will receive monthly text message reminders from study staff to refill ART prescriptions, and a separate reminder in month 6 to schedule complete their 6-month clinical visit. Study staff will verify that participants have picked up medications and attended all scheduled clinical visits by means of chart review and data extraction. Per MPDOH guidelines, individuals who fail to collect medications 3 months in a row, or who fail to attend their 6-month HIV clinical follow-up appointment, will be considered non-engaged and lost to follow up (LTFU).
Intervention Type
Behavioral
Intervention Name(s)
Peer Navigation
Intervention Description
Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.
Primary Outcome Measure Information:
Title
Viral Suppression
Description
The proportion of participants virally suppressed (HIV RNA <1000 copies/microliter) in Peer Navigation (Intervention) arm compared to standard of care (SOC) arm.
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
As this study focuses on men who have sex with men, only persons born male are included.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheri Lippman, PhD
Organizational Affiliation
University of California, San Francsico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anova Health Institute
City
Nelspruit
State/Province
Mpumalanga
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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