Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
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|ClinicalTrials.gov Identifier: NCT03483857|
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hiv||Behavioral: Peer Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa|
|Actual Study Start Date :||September 21, 2017|
|Actual Primary Completion Date :||June 29, 2018|
|Actual Study Completion Date :||June 29, 2018|
Experimental: 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.
Behavioral: Peer Navigation
Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.
No Intervention: 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).
- Viral Suppression [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483857
|Anova Health Institute|
|Nelspruit, Mpumalanga, South Africa|
|Principal Investigator:||Sheri Lippman, PhD||University of California, San Francsico|