Interventions for Improved Post-partum ART Continuation and HIV Testing of Male Partners of Women in PMTCT B+ in Uganda (Kingasa Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Viral suppression
研究概览
简要总结
In the Kingasa study, the investigators will use a factorial design in order to evaluate both an intervention to increase male partner HIV testing and an intervention for pregnant and postpartum women living with HIV to provide real-time HIV VL load and ART adherence counseling. Specifically, the investigators will evaluate a) whether invitations to wellness visits increase the proportion of male partners who test for HIV and b) whether POC HIV VL tests increase viral suppression among pregnant and postpartum women living with HIV. The research team will also assess the impact of providing male counselor phone call follow-up to men in the wellness visit arm to encourage linkage to HIV care and prevention after HIV testing. Women will be randomized 1:1:1:1 to receive a) standard of care interventions with an invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing for women at enrollment and every 6 months until 12 months postpartum, b) invitation letter for male partners for fast track visit for HIV testing and POC VL tests for women at enrollment and every 6 months until 12 months postpartum; c) invitation letter to male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment and every 6 months until 12 months postpartum; and d) invitation letter to male partners for wellness visits and POC viral load testing for women at enrollment and every 6 months until 12 months post-partum. Women who are randomized to receive POC VL will receive same-day ART adherence counseling and those randomized to receive lab-based VL will receive VL results at their next visit with ART adherence counseling based on their VL results.
详细描述
In the Kingasa study, the investigators will use a factorial design in order to evaluate both an intervention to increase male partner HIV testing and an intervention for pregnant and postpartum women living with HIV to provide real-time HIV VL load and ART adherence counseling. Specifically, the investigators will evaluate a) whether invitations to wellness visits increase the proportion of male partners who test for HIV and b) whether POC HIV VL tests increase viral suppression among pregnant and postpartum women living with HIV. The research team will also assess the impact of providing male counselor phone call follow-up to men in the wellness visit arm to encourage linkage to HIV care and prevention after HIV testing. Women will be randomized 1:1:1:1 to receive a) standard of care interventions with an invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing for women at enrollment and every 6 months until 12 months postpartum, b) invitation letter for male partners for fast track visit for HIV testing and POC VL tests for women at enrollment and every 6 months until 12 months postpartum; c) invitation letter to male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment and every 6 months until 12 months postpartum; and d) invitation letter to male partners for wellness visits and POC viral load testing for women at enrollment and every 6 months until 12 months post-partum. Women who are randomized to receive POC VL will receive same day ART adherence counseling and those randomized to receive lab based VL will receive VL results at their next visit with ART adherence counseling based on their VL results.
Women in both arms will receive counseling to minimize social harms associated with status disclosure and HIV testing, and additional counseling and referral to social support services when social harms occur. Based on the current Ugandan MOH guidelines to offer HIVST to both HIV-positive and HIV-negative pregnant women in ANC clinics, women in both arms will be provided an HIVST to give to their partner if they choose. They will be trained in the use and interpretation of the HIVST and be given information about HIV testing and prevention and care services, which she will give to her partner.
This study has been designed to address the gap in male partner engagement by using innovative methods to link men to HIV testing, prevention and care, and thus PMTCT outcomes for women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 or 14-17 years if an emancipated minor (pregnant or have a child)
- •Currently pregnant
- •Not currently enrolled in an HIV treatment study
- •Male partner not known to be HIV-positive or has not tested in the past 3 months
- •Able and willing to provide written informed consent
- •Able and willing to provide adequate locator information for study retention purposes
- •Screening negative for any indication of intimate partner violence or social harm
- •Inclusion Criteria for men:
- •female partner enrolled in Kingasa pilot study
排除标准
- 未提供
研究组 & 干预措施
Female SOC/Male SOC arm
Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing at enrollment and every 6 months until 6 months postpartum,
Female intervention/Male SOC arm
Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and POC VL tests for women at enrollment, delivery, and 6 months post-partum;
干预措施: POC viral load testing (Diagnostic Test)
Female SOC/Male intervention arm
Women will be provided an invitation letter for male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment, delivery, and 6 months post-partum;
干预措施: Wellness visit services for male partners (Other)
Female intervention/male intervention arm
Women will be provided an invitation letter for male partners invitation letter for male partners for wellness visits and POC viral load testing for women at enrollment, delivery, and 6 months post-partum.
干预措施: POC viral load testing (Diagnostic Test)
Female intervention/male intervention arm
Women will be provided an invitation letter for male partners invitation letter for male partners for wellness visits and POC viral load testing for women at enrollment, delivery, and 6 months post-partum.
干预措施: Wellness visit services for male partners (Other)
结局指标
主要结局
Viral suppression
时间窗: 6 months post-partum
To compare viral suppression (defined as less than 50 copies/mL) at 6 months post-partum among women in the intervention arm (receiving POC viral load testing and same-day ART adherence support) to women in the control arm (receiving stand of care lab-based HIV VL testing).
Acceptability evaluation
时间窗: One time point at 3 months post-partum for women, and one time point at 3 months post enrollment for men
To evaluate acceptability and preferences for HIV testing and other health services among 15 pregnant women and 15 male partners using qualitative in-depth interviews.
Male partner HIV testing
时间窗: 6 months from female partner enrollment
To determine the proportion of male partners of pregnant HIV-positive women who test for HIV at the clinic, based on invitation to a wellness visit (dual syphilis and HIV rapid test, blood pressure, visual acuity screening and COVID symptom screening, and if available, PCR testing for those with symptoms) compared to the standard of care (standard of care invitation letter for HIV fast track testing at the clinic).
Male partner linkage
时间窗: 6 months from female partner enrollment
To assess the proportion of HIV-negative male partners who initiate PrEP and HIV positive men who initiate ART among male partners who test for HIV and are provided male counselor phone follow up or who receive standard of care.
次要结局
未报告次要终点
研究者
Connie Celum
Professor of Global Health, Medicine, and Epidemiology
University of Washington
