A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women With HIV in Botswana
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Mental bandwidth: Psychomotor Vigilance Task
研究概览
简要总结
The goal of this study is to evaluate the effectiveness and implementation of an unconditional cash transfer intervention to improve mental bandwidth, ART adherence, and postpartum retention among pregnant women with HIV in Botswana.
The main questions it seeks to answer are:
- Do unconditional monthly cash transfers improve mental bandwidth relative to usual care among pregnant women with HIV?
- Do unconditional monthly cash transfers improve ART adherence (PDC) during pregnancy and the postpartum period?
- Is delivery of UCTs via mobile money feasible and acceptable in public ANC clinics in Botswana?
- What barriers and facilitators affect implementation, and how should the model be adapted for a larger trial or a policy pilot (e.g., a pregnancy support grant)?
详细描述
Poverty is an important contributor to poor short- and long-term HIV outcomes for pregnant women with HIV. This problem is salient in Botswana, where antenatal HIV prevalence is >20%. Poverty has been reported as a major barrier to sustained engagement in ART among pregnant women with HIV, and extreme poverty affects 15-20% of people in Botswana. Recent research in behavioral economics has shown that poverty can result in worse health outcomes by taxing mental bandwidth, resulting in a heightened focus on immediate needs and less attention to future-oriented decisions. Mental bandwidth is likely further taxed by the added burdens of HIV and the perinatal period. Consequently, anti-poverty interventions targeting pregnant women with HIV, such as cash transfers, may be particularly effective at improving health outcomes. However, equipoise remains about the role of cash transfers in HIV, with prior studies showing mixed results (e.g., HPTN068 showing no reduction in HIV incidence among school-aged girls receiving cash transfers in South Africa). In addition, there is a policy relevant question of whether and to what extent a pregnancy support grant could help improve outcomes.
In this study, we will conduct a pilot Hybrid Type 2 effectiveness-implementation trial of an unconditional cash transfer intervention for pregnant women with HIV. This research will be conducted at antenatal clinics managed by the District Health Management Teams in Gaborone (e.g., Old Naledi, Mafitlakgosi) and Mogoditsane-Thamaga District (e.g., Lesirane). It will be a collaboration between the University of Botswana and the University of Pennsylvania, through the Botswana-Upenn-Partnership. The study population will be comprised of pregnant women with HIV receiving antenatal care. We will enroll a total of 100 participants in their second trimester - 50 assigned to the usual care arm (standard social support), and 50 assigned to the intervention arm (the addition of 1000 BWP per month through 6 months post partum). All participants will complete study visits at baseline (Visit 1), late pregnancy prior to delivery (Visit 2), and 3-6 months post-partum (Visit 3). Data collected at study visits will include survey questionnaires, bandwidth assessments, and clinical data from the electronic health record database. During the final study visit, we will recruit 20 participants (15 intervention, 5 control; randomly selected) for individual qualitative interviews.
Primary outcomes will include mental bandwidth and ART adherence (effectiveness outcomes), and feasibility and acceptability of the intervention (implementation outcomes). These findings will be used as the basis for an NIH R01 proposal to conduct a larger trial of an unconditional cash transfer powered for clinical outcomes (e.g., postpartum viral suppression).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or greater
- •Botswana citizen
- •Seeking/receiving antenatal care at antenatal clinics managed by the District Health Management Teams in Gaborone and Mogoditsane-Thamaga District
- •Confirmed pregnancy by standard laboratory methods (generally urine testing)
- •HIV seropositive
- •Economically vulnerable (self-reported annual income below the Botswana poverty line of 14,000 BWP per year, equivalent to the international poverty line of $2.15 in 2017 purchasing power parity)
排除标准
- •Does not meet all of the inclusion criteria
- •Unable to provide consent
- •Cognitive impairment, per discretion of study staff
- •Cannot be in the same household as another enrolled study participant
研究组 & 干预措施
Cash-Transfer Intervention
Receives usual care and Unconditional Cash Transfers (UCTs) of 1,000 BWP/month
干预措施: Unconditional Cash Transfer (UCT) (Other)
Usual care
Receives usual care and standard social support
结局指标
主要结局
Mental bandwidth: Psychomotor Vigilance Task
时间窗: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Results from Psychomotor Vigilance Task (response time, number of minor lapses and false starts)
Mental bandwidth: Raven's Progressive Matrices
时间窗: Baseline visit, gestational age ≥30 weeks (visit 2), 3-6 months post-partum (visit 3)
Raven's Progressive Matrices short form (number of correct answers)
Antiretroviral Therapy (ART) adherence
时间窗: From baseline visit through 6 months post-partum
Proportion of doses covered: Sum of days covered by dispensed medication in the observation period) / (Total number of days in the observation period). This is using pharmacy refill data.
Feasibility of intervention
时间窗: At gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3); qualitative interviews are 3-8 months post-partum
Feasibility of Intervention Measure, 4-item scale (1-4), higher score indicates greater feasibility; Qualitative interview
Acceptability of intervention
时间窗: At gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3); qualitative interviews are 3-8 months post-partum
Acceptability of Intervention Measure, 4-item scale (1-4), higher score indicates greater acceptability; Qualitative interview
Antiretroviral Therapy (ART) adherence
时间窗: From baseline visit through 6 months post-partum
Proportion of doses covered: Sum of days covered by dispensed medication in the observation period) / (Total number of days in the observation period). This is using pharmacy refill data.
Mental bandwidth: Psychomotor Vigilance Task
时间窗: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Results from Psychomotor Vigilance Task (response time, number of minor lapses and false starts)
Mental bandwidth: Raven's Progressive Matrices
时间窗: Baseline visit, gestational age ≥30 weeks (visit 2), 3-6 months post-partum (visit 3)
Raven's Progressive Matrices short form (number of correct answers)
Feasibility of intervention
时间窗: At gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3); qualitative interviews are 3-8 months post-partum
Feasibility of Intervention Measure, 4-item scale (1-4), higher score indicates greater feasibility; Qualitative interview
Acceptability of intervention
时间窗: At gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3); qualitative interviews are 3-8 months post-partum
Acceptability of Intervention Measure, 4-item scale (1-4), higher score indicates greater acceptability; Qualitative interview
次要结局
- Food security(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Time Preferences (Future Orientation)(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Time Horizon(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Hope(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Stress(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Psychological Distress(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Pregnancy status: pregnant or post-partum(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Location of delivery(At 3-6 months post-partum (visit 3))
- Gestational age at delivery(At 3-6 months post-partum (visit 3))
- Birth outcome(3-6 months post-partum (visit 3))
- Antenatal HIV clinic attendance(From baseline visit through 6 months post-partum)
- Post-partum HIV clinic attendance(From baseline visit through 6 months post-partum)
- Food security(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Time Preferences (Future Orientation)(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Time Horizon(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Hope(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Stress(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Psychological Distress(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Pregnancy status: pregnant or post-partum(At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3))
- Location of delivery(At 3-6 months post-partum (visit 3))
- Gestational age at delivery(At 3-6 months post-partum (visit 3))
- Birth outcome(3-6 months post-partum (visit 3))
- Antenatal HIV clinic attendance(From baseline visit through 6 months post-partum)
- Post-partum HIV clinic attendance(From baseline visit through 6 months post-partum)
