Cash Transfers to Pregnant Women With HIV

NCT ID: NCT07226492

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2028-01-04

Brief 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)?

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).

Conditions

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

Keywords

Cash-transfer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cash-Transfer Intervention

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

Group Type: EXPERIMENTAL

Unconditional Cash Transfer (UCT)

Intervention Type: OTHER

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

Usual care

Receives usual care and standard social support

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Unconditional Cash Transfer (UCT)

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Unable to provide consent
• Cognitive impairment, per discretion of study staff
• Cannot be in the same household as another enrolled study participant

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Botswana

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lesirane Clinc

Gaborone, , Botswana

Mafitlhakgosi Clinic

Gaborone, , Botswana

Old Naledi Clinic

Gaborone, , Botswana

Countries

Botswana

Central Contacts

Aaron G Richterman, MD, MPH

Role: CONTACT

Phone: 267-441-7915

Email: Aaron.Richterman@Pennmedicine.upenn.edu

Charlotte N Babbin, BA

Role: CONTACT

Phone: 2039151038

Email: charlotte.babbin@pennmedicine.upenn.edu

Facility Contacts

Aaron G Richterman, MD, MPH

Role: primary

Aaron G Richterman, MD, MPH

Role: primary

Aaron G Richterman, MD, MPH

Role: primary

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28851459 (View on PubMed)

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.

Reference Type: BACKGROUND

Laajaj R. Endogenous time horizon and behavioral poverty trap: Theory and evidence from Mozambique. Journal of Development Economics. 2017;127:187-208.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 8636885 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6668417 (View on PubMed)

Other Identifiers

4K23MH131464-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

857193

Identifier Type: -

Identifier Source: org_study_id