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)?
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Unconditional Cash Transfer (UCT) of 1,000 BWP/month
Lesirane Clinc
Gaborone, Botswana
NOT_YET_RECRUITINGMafitlhakgosi Clinic
Gaborone, Botswana
NOT_YET_RECRUITINGOld Naledi Clinic
Gaborone, Botswana
RECRUITINGAntiretroviral Therapy (ART) adherence
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.
Time frame: From baseline visit through 6 months post-partum
Mental bandwidth: Psychomotor Vigilance Task
Results from Psychomotor Vigilance Task (response time, number of minor lapses and false starts)
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Mental bandwidth: Raven's Progressive Matrices
Raven's Progressive Matrices short form (number of correct answers)
Time frame: Baseline visit, gestational age ≥30 weeks (visit 2), 3-6 months post-partum (visit 3)
Feasibility of intervention
Feasibility of Intervention Measure, 4-item scale (1-4), higher score indicates greater feasibility; Qualitative interview
Time frame: 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
Acceptability of Intervention Measure, 4-item scale (1-4), higher score indicates greater acceptability; Qualitative interview
Time frame: At gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3); qualitative interviews are 3-8 months post-partum
Food security
Household Hunger Scale - measures the severity of hunger in a household based on experiences of food deprivation over the past 30 days, scale of 1-3, higher number indicates lower food security
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Time Preferences (Future Orientation)
Preference Survey Module - measures self-described temporal discounting with a 10-point probabilistic scale; Patience (Brownback) - measures number of weeks willing to wait for an increased payment (delayed economic gratification)
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Time Horizon
Time Horizon (Laajaj) - length of time finances are planned in advance
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Hope
State Hope Scale, 8-item scale - self-report measure of goal directed thinking, values 1-8, higher value indicates greater hope
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Stress
Perceived Stress Scale-4, 5-item scale (assessment of perceived stress over the past 30 days), values 1-5
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Psychological Distress
Kessler 6+ (assessment of frequency of psychological distress symptoms over the past 30 days), values 1-5, higher value indicates greater distress
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Pregnancy status: pregnant or post-partum
Self-reported status of pregnancy (pregnant or post-partum)
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Location of delivery
Collected from the electronic health record database: whether participant gave birth at a health facility, home, or other
Time frame: At 3-6 months post-partum (visit 3)
Gestational age at delivery
Gestational age at delivery, collected from electronic health record database
Time frame: At 3-6 months post-partum (visit 3)
Birth outcome
Collected from electronic health record database: live birth (child is alive), live birth (child is deceased), still birth, miscarriage, or other
Time frame: 3-6 months post-partum (visit 3)
Antenatal HIV clinic attendance
From electronic health record database: number of attended visits, number of scheduled visits
Time frame: From baseline visit through 6 months post-partum
Post-partum HIV clinic attendance
From electronic health record database: number of attended visits, number of scheduled visits
Time frame: From baseline visit through 6 months post-partum
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.