- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07226492
Cash Transfers to Pregnant Women With HIV
A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women With HIV in Botswana
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)?
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aaron G Richterman, MD, MPH
- Phone Number: 267-441-7915
- Email: Aaron.Richterman@Pennmedicine.upenn.edu
Study Contact Backup
- Name: Charlotte N Babbin, BA
- Phone Number: 2039151038
- Email: charlotte.babbin@pennmedicine.upenn.edu
Study Locations
-
-
-
Gaborone, Botswana
- Not yet recruiting
- Lesirane Clinc
-
Contact:
- Aaron G Richterman, MD, MPH
- Phone Number: 267-441-7915
- Email: Aaron.Richterman@Pennmedicine.upenn.edu
-
Gaborone, Botswana
- Not yet recruiting
- Mafitlhakgosi Clinic
-
Contact:
- Aaron G Richterman, MD, MPH
- Phone Number: 267-441-7915
- Email: Aaron.Richterman@Pennmedicine.upenn.edu
-
Gaborone, Botswana
- Recruiting
- Old Naledi Clinic
-
Contact:
- Aaron G Richterman, MD, MPH
- Phone Number: 267-441-7915
- Email: Aaron.Richterman@Pennmedicine.upenn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
- <20 weeks gestational age (by ultrasound dating)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cash-Transfer Intervention
Receives usual care and Unconditional Cash Transfers (UCTs) of 1,000 BWP/month
|
Unconditional Cash Transfer (UCT) of 1,000 BWP/month
|
|
No Intervention: Usual care
Receives usual care and standard social support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental bandwidth: Psychomotor Vigilance Task
Time Frame: 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)
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Mental bandwidth: Raven's Progressive Matrices
Time Frame: 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)
|
Baseline visit, gestational age ≥30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Antiretroviral Therapy (ART) adherence
Time Frame: 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.
|
From baseline visit through 6 months post-partum
|
|
Feasibility of intervention
Time Frame: 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
|
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
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 Measure, 4-item scale (1-4), higher score indicates greater acceptability; Qualitative interview
|
At gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3); qualitative interviews are 3-8 months post-partum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food security
Time Frame: 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
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Time Preferences (Future Orientation)
Time Frame: 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)
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Time Horizon
Time Frame: 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
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Hope
Time Frame: 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
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Stress
Time Frame: 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
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Pregnancy status: pregnant or post-partum
Time Frame: 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)
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
|
Location of delivery
Time Frame: 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
|
At 3-6 months post-partum (visit 3)
|
|
Gestational age at delivery
Time Frame: At 3-6 months post-partum (visit 3)
|
Gestational age at delivery, collected from electronic health record database
|
At 3-6 months post-partum (visit 3)
|
|
Birth outcome
Time Frame: 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
|
3-6 months post-partum (visit 3)
|
|
Antenatal HIV clinic attendance
Time Frame: From baseline visit through 6 months post-partum
|
From electronic health record database: number of attended visits, number of scheduled visits
|
From baseline visit through 6 months post-partum
|
|
Post-partum HIV clinic attendance
Time Frame: From baseline visit through 6 months post-partum
|
From electronic health record database: number of attended visits, number of scheduled visits
|
From baseline visit through 6 months post-partum
|
|
Psychological Distress
Time Frame: 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
|
At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.
- Laajaj R. Endogenous time horizon and behavioral poverty trap: Theory and evidence from Mozambique. Journal of Development Economics. 2017;127:187-208.
- Falk A, Becker A, Dohmen T, Huffman D, Sunde U. The Preference Survey Module: A Validated Instrument for Measuring Risk, Time, and Social Preferences. Human Capital and Economic Opportunity Working Group;2016.
- Deitchler M, Ballard T, Swindale A, Coates J. Introducing a simple measure of household hunger for cross-cultural use. Washington, DC: Food and Nutrition Technical Assistance II project, AED. 2011.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 857193
- 4K23MH131464-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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