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临床试验/NCT07226492
NCT07226492招募中不适用

A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women With HIV in Botswana

University of Pennsylvania8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月9日最近更新:
适应症
干预措施

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:

  1. Do unconditional monthly cash transfers improve mental bandwidth relative to usual care among pregnant women with HIV?
  2. Do unconditional monthly cash transfers improve ART adherence (PDC) during pregnancy and the postpartum period?
  3. Is delivery of UCTs via mobile money feasible and acceptable in public ANC clinics in Botswana?
  4. 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

Experimental

Receives usual care and Unconditional Cash Transfers (UCTs) of 1,000 BWP/month

干预措施: Unconditional Cash Transfer (UCT) (Other)

Usual care

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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