Menu
Recruiting NCT07226492

Cash Transfers to Pregnant Women With HIV

No phase Interventional HIV Pregnancy HIV Antiretroviral Therapy (ART) Adherence Post-partum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unconditional Cash Transfer (UCT).
Who it may be relevant to
Registry conditions: HIV, Pregnancy, HIV Antiretroviral Therapy (ART) Adherence, Post-partum. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Botswana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Antiretroviral Therapy (ART) adherence [Time frame: From baseline visit through 6 months post-partum]
  • Mental bandwidth: Psychomotor Vigilance Task [Time frame: At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)]
  • Mental bandwidth: Raven's Progressive Matrices [Time frame: Baseline visit, gestational age ≥30 weeks (visit 2), 3-6 months post-partum (visit 3)]
  • 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]
  • 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]
Secondary outcome measures (12)
  • 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]

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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Botswana · 8 centers
  • 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

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. PMID 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. PMID 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. PMID 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.

Identifiers

NCT: NCT07226492 · 857193 · 4K23MH131464-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗