Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Viral Suppression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Peer Navigation (Behavioral)
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).
结局指标
主要结局
Viral Suppression
时间窗: 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.
次要结局
未报告次要终点