Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
NCT ID: NCT03483857
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2017-09-21
2018-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Peer Navigation
Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.
Standard of Care
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).
No interventions assigned to this group
Interventions
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Peer Navigation
Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.
Eligibility Criteria
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Inclusion Criteria
* 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 laboratory or documentary evidence of HIV diagnosis.
18 Years
MALE
No
Sponsors
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ANOVA Health Institute
UNKNOWN
National Institutes of Health (NIH)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Sheri Lippman, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francsico
Locations
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Anova Health Institute
Mbombela, Mpumalanga, South Africa
Countries
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Other Identifiers
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