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| Name | Class |
|---|---|
| ANOVA Health Institute | UNKNOWN |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Navigation | Experimental | 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. |
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| Standard of Care | No 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Navigation | Behavioral | Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
As this study focuses on men who have sex with men, only persons born male are included.
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| Name | Affiliation | Role |
|---|---|---|
| Sheri Lippman, PhD | University of California, San Francsico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anova Health Institute | Mbombela | Mpumalanga | South Africa |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |