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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women With HIV in Botswana
- ClinicalTrials.gov ID
- NCT07226492
- Acronym / sponsor ID
- 857193
- Keywords
- Cash-transfer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Botswana, National Institute of Mental Health (NIMH)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 4 Jan 2028 (estimated)
- Study completion
- 4 Jan 2028 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cash-Transfer Intervention | Experimental | Other: Unconditional Cash Transfer (UCT)Receives usual care and Unconditional Cash Transfers (UCTs) of 1,000 BWP/month |
| Usual care | No intervention | –Receives usual care and standard social support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unconditional Cash Transfer (UCT)Unconditional Cash Transfer (UCT) of 1,000 BWP/month | Other | Cash-Transfer Intervention |
Primary outcome
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.
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)
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)
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
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
12 secondary outcomes
Food security
Time frame: 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)
Time Horizon
Time frame: 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)
Stress
Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)
Psychological 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
Time frame: 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)
Gestational age at delivery
Time frame: At 3-6 months post-partum (visit 3)
Birth outcome
Time frame: 3-6 months post-partum (visit 3)
Antenatal HIV clinic attendance
Time frame: From baseline visit through 6 months post-partum
Post-partum HIV clinic attendance
Time frame: From baseline visit through 6 months post-partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 8636885Snyder 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.
- BackgroundLaajaj R. Endogenous time horizon and behavioral poverty trap: Theory and evidence from Mozambique. Journal of Development Economics. 2017;127:187-208.
- BackgroundFalk 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.
- Background: PubMed 28851459Weiner 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.
- BackgroundDeitchler 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.
- Individual participant dataSharing planned: No. Sharing IPD is not part of the study's protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unconditional Cash Transfer (UCT) in people with HIV and Pregnancy, run by University of Pennsylvania at 8 sites in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiretroviral Therapy (ART) adherence (time frame: From baseline visit through 6 months post-partum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07226492, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.