Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Retention and viral suppression
研究概览
简要总结
Young pregnant and postpartum women living with HIV are at the greatest risk of disengagement from HIV services and suboptimal adherence to antiretroviral therapy (ART). Among young women, stigma is a major barrier to retention in services and adherence to ART, and interventions are needed to combat stigma and improve ART outcomes. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in this population.
详细描述
Despite major reductions in mother-to-child HIV transmission (MTCT), young pregnant and postpartum women living with HIV remain a vulnerable group and experience the greatest risk of disengagement from services and suboptimal adherence to antiretroviral therapy (ART). HIV-related and intersectional stigmas are major barriers to uptake and retention in prevention of mother-to-child transmission (PMTCT) services and drive suboptimal adherence, and young women experience unique stigmas. Despite this, there are no evidence-based interventions to combat stigma and improve ART outcomes in this group. Peer support group interventions have shown promise in other populations, but have not been examined in young pregnant and postpartum women living with HIV. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in young pregnant and postpartum women living with HIV in South Africa. Participants will be allocated to the standard of care, in which no standardized peer support groups exist for this patient population, or to a peer support intervention.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 16-24 years
- •Documented HIV infection
- •Confirmed pregnant or recently postpartum
- •Accessing antenatal or immediate postpartum PMTCT services at the study site
- •Planning on remaining a resident of Cape Town for at least 6 months after enrolment
- •Able to provide informed consent for research
排除标准
- •Significant pre-existing psychiatric comorbidity that may impact ability to consent
- •Stated intention to move outside of Cape Town during the 6 months after enrolment
研究组 & 干预措施
Local standard of care
Women receive integrated antenatal and HIV services during pregnancy and are referred to general adult HIV services after delivery; no standardized peer support groups exist for this patient population.
Peer support intervention
Women will be invited to attend monthly peer support groups during pregnancy and postpartum, separate from any routine health services.
干预措施: Peer support intervention (Behavioral)
结局指标
主要结局
Retention and viral suppression
时间窗: After 6 months of follow-up
Combined endpoint of (i) retention in HIV services and (ii) HIV viral suppression. Women will be considered to have achieved the primary outcome if they are both retained in care and virally suppressed.
次要结局
- Psychosocial outcomes(6 months)
- Implementation of the intervention(6 months)
- Acceptability of the intervention(6 months)
- Health status(6 months)
- Health service use(6 months)
研究者
Professor Landon Myer
Professor
University of Cape Town