Promoting HIV Health Behaviors Among Pregnant Couples in Zambia Using an Adaptive Relationship Strengthening Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Female Viral Suppression
研究概览
简要总结
The objective of this study is to test the preliminary efficacy of a novel couples' counseling intervention to promote the health of pregnant women living with HIV in Lusaka, Zambia.
详细描述
The central hypothesis of this study is that women living with HIV in heterosexual couples that have better relationship functioning and more social support will have greater odds of achieving optimal health during and after pregnancy. The study further hypothesizes that the couples-based intervention will improve interpersonal dynamics, such as communication, and in intrapersonal factors, such as women's mental health, which will mediate intervention effects on HIV care and treatment outcomes. The study will test the hypotheses through two specific aims: (1) compare service utilization and prevention of mother-to-child transmission (PMTCT) outcome indicators in two study conditions; and (2) establish the effect of the intervention on intra- and inter-personal mechanisms influencing outcomes.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Heterosexual couple in a stable relationship (defined as sleeping under the same roof at least once a week)
- •Relationship has lasted ≥ 6 months
- •Both partners live in the clinic catchment area and plan to continue residing there for at least six months
- •Both partners are at least 18 years of age
- •Both partners willing to participate in the intervention
- •Female partner is no more than 36 weeks pregnant
- •Female partner is diagnosed as HIV-positive
- •Severe intimate partner violence (World Health Organization definition) has not occurred within the couple in the past 6 months.
排除标准
- •Same-sex couple
- •couple who does not sleep under the same roof at least once a week
- •Relationship has lasted <6 months
- •One or both partners live outside the clinic catchment area
- •One or both partners plan to move outside the clinic catchment area
- •One or both partners are <18 years of age
- •One or both partners unwilling to participate in the intervention
- •Female partner is greater than 36 weeks pregnant
- •Female partner is HIV-negative
- •Severe intimate partner violence (World Health Organization definition) has occurred within the couple in the past 6 months.
研究组 & 干预措施
Couples Counseling Intervention
Couples in the intervention group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health, as well as three couple counseling visits (one during pregnancy and two postpartum). The couples counseling sessions will provide (1) information on key relationship topics (communication, trust and respect, love and support); (2) relationship skills exercises (role playing); and (3) the opportunity to discuss health and relationship priorities/goals of the couple.
干预措施: Couples Counseling (Behavioral)
Control
Couples assigned to the control group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health. Couples will also have the opportunity after the trial is complete to opt-in to receive a condensed one-session couples counseling visit (data not to be used for study purposes but offered for ethical reasons).
干预措施: Enhanced Standard of Care (Other)
结局指标
主要结局
Female Viral Suppression
时间窗: Month 6 postpartum
Laboratory testing of blood samples. A result of \<1,000 HIV viral copies/mL indicates viral suppression.
次要结局
- Self-reported postpartum use of family planning(Month 6 postpartum)
- Self-reported 30-day antiretroviral therapy adherence(Month 6 postpartum)
- Self-reported exclusive breastfeeding(Month 6 postpartum)
- Self-reported infant HIV testing(Month 6 postpartum)