HIV, HIV Antiretroviral Therapy (ART) Adherence, Post-partum, Pregnancy
Conditions
Keywords
Cash-transfer
Brief summary
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)?
Detailed description
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).
Interventions
Unconditional Cash Transfer (UCT) of 1,000 BWP/month
Sponsors
University of Pennsylvania
University of Botswana
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Therapy (ART) adherence | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food security | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) | 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 Preferences (Future Orientation) | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) | 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 Horizon | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) | Time Horizon (Laajaj) - length of time finances are planned in advance |
| Hope | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) | State Hope Scale, 8-item scale - self-report measure of goal directed thinking, values 1-8, higher value indicates greater hope |
| Stress | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) | Perceived Stress Scale-4, 5-item scale (assessment of perceived stress over the past 30 days), values 1-5 |
| Psychological Distress | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) | Kessler 6+ (assessment of frequency of psychological distress symptoms over the past 30 days), values 1-5, higher value indicates greater distress |
| Pregnancy status: pregnant or post-partum | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) | Self-reported status of pregnancy (pregnant or post-partum) |
| Location of delivery | At 3-6 months post-partum (visit 3) | Collected from the electronic health record database: whether participant gave birth at a health facility, home, or other |
| Gestational age at delivery | At 3-6 months post-partum (visit 3) | Gestational age at delivery, collected from electronic health record database |
| Birth outcome | 3-6 months post-partum (visit 3) | Collected from electronic health record database: live birth (child is alive), live birth (child is deceased), still birth, miscarriage, or other |
| Antenatal HIV clinic attendance | From baseline visit through 6 months post-partum | From electronic health record database: number of attended visits, number of scheduled visits |
| Post-partum HIV clinic attendance | From baseline visit through 6 months post-partum | From electronic health record database: number of attended visits, number of scheduled visits |
Countries
Botswana
Contacts
CONTACTAaron G Richterman, MD, MPH
CONTACTCharlotte N Babbin, BA
Outcome results
None listed