HIVNCT07226492
Cash Transfers to Pregnant Women With HIV
A study testing Unconditional Cash Transfer (UCT) in people with HIV and Pregnancy, run by University of Pennsylvania at 8 sites in Botswana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Pregnancy, HIV Antiretroviral Therapy (ART) Adherence
- What is being tested?
- Unconditional Cash Transfer (UCT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesBotswana
- Study dates
- 9 Mar 2026to 4 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Botswana8 sites
Bontleng Clinic
Gaborone
Broadhurst 3
Gaborone
GWest Clinic
Gaborone
Lesirane Clinc
Gaborone
Mafitlhakgosi Clinic
Gaborone
Mogoditshane Clinic
Gaborone
Nkoyaphiri Clinic
Gaborone
Old Naledi Clinic
Gaborone
About this study
Official title: 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)?
Read the 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).
- Being tested
- Unconditional Cash Transfer (UCT)
- Keywords
- Cash-transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconditional Cash Transfer (UCT)Other
Unconditional Cash Transfer (UCT) of 1,000 BWP/month
| Study group | Role | What they receive |
|---|---|---|
| Cash-Transfer Intervention | Experimental | Receives usual care and Unconditional Cash Transfers (UCTs) of 1,000 BWP/month Receives: Other: Unconditional Cash Transfer (UCT) |
| Usual care | No intervention | Receives usual care and standard social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: At gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3); qualitative interviews are 3-8 months post-partum
Secondary outcomes (12)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: At 3-6 months post-partum (visit 3)
Gestational age at delivery
Gestational age at delivery, collected from electronic health record database
Measured: 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
Measured: 3-6 months post-partum (visit 3)
Antenatal HIV clinic attendance
From electronic health record database: number of attended visits, number of scheduled visits
Measured: 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
Measured: From baseline visit through 6 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start9 Mar 2026
- Primary completion4 Jan 2028 (estimated)
- Study completion4 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Botswana, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226492
- Sponsor's protocol ID
- 857193
- Other IDs
- 4K23MH131464-04
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD is not part of the study's protocol.
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.
PubMed 6668417Snyder 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.
PubMed 8636885Laajaj 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.
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.
PubMed 28851459Deitchler 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.