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NCT Number: NCT07226492

Cash Transfers to Pregnant Women With HIV

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)?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bontleng Clinic, Gaborone, Botswana

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unconditional Cash Transfer (UCT)

Other

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

Primary outcomes

  1. 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.

  2. 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)

  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)

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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)

  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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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

  9. Gestational age at delivery

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

    Gestational age at delivery, collected from electronic health record database

  10. 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

  11. 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

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron G Richterman, MD, MPH

CONTACT

[email protected]

267-441-7915

Charlotte N Babbin, BA

CONTACT

[email protected]

2039151038

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Botswana

Registry information

Official study title

A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women With HIV in Botswana

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 10, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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