ClinicalTrials.gg
Active, not recruitingNCT07226492Updated Oct 2, 2026

Cash Transfers to Pregnant Women With HIV

An interventional study of Unconditional Cash Transfer (UCT) in HIV, Pregnancy and HIV Antiretroviral Therapy (ART) Adherence, sponsored by University of Pennsylvania. Active, not recruiting at 8 sites in Botswana. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Supportive care

Updated Oct 2, 2026Now Active, not recruitingGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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)?
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).

02

Conditions studied

  • HIV
  • Pregnancy
  • HIV Antiretroviral Therapy (ART) Adherence
  • Post-partum

Keywords

  • Cash-transfer
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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)
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Cash-Transfer Intervention

    Receives usual care and Unconditional Cash Transfers (UCTs) of 1,000 BWP/month

    Other: Unconditional Cash Transfer (UCT)

  • No intervention
    Usual care

    Receives usual care and standard social support

Interventions

  • OtherUnconditional Cash Transfer (UCT)

    Unconditional Cash Transfer (UCT) of 1,000 BWP/month

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline visit through 6 months post-partum

  2. 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)

  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)

  4. 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

  5. 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

Secondary outcomes

  1. 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)

  2. 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)

  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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. Gestational age at delivery

    Gestational age at delivery, collected from electronic health record database

    Time frame: At 3-6 months post-partum (visit 3)

  10. 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)

  11. 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

  12. 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

07

Study locations

8 sites
  • Bontleng Clinic
    Gaborone, Botswana
  • Broadhurst 3
    Gaborone, Botswana
  • GWest Clinic
    Gaborone, Botswana
  • Lesirane Clinc
    Gaborone, Botswana
  • Mafitlhakgosi Clinic
    Gaborone, Botswana
  • Mogoditshane Clinic
    Gaborone, Botswana
  • Nkoyaphiri Clinic
    Gaborone, Botswana
  • Old Naledi Clinic
    Gaborone, Botswana
08

References and documents

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 6668417 ↗
  • 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. PubMed 8636885 ↗
  • 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.
  • 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 28851459 ↗
  • 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.

Individual participant data

Plan to share: No — Sharing IPD is not part of the study's protocol.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Jan 2028, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2025
First posted
Nov 10, 2025
StartActual
Mar 9, 2026
Primary completionEst.
Jan 4, 2028
CompletionEst.
Jan 4, 2028
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07226492
Collaborators
University of Botswana, National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Nov 10, 2025
Start date
Mar 9, 2026
Primary completion
Jan 4, 2028 (estimated)
Completion
Jan 4, 2028 (estimated)
Last update
Oct 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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