NCT07226492

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. 1.Do unconditional monthly cash transfers improve mental bandwidth relative to usual care among pregnant women with HIV?
  2. 2.Do unconditional monthly cash transfers improve ART adherence (PDC) during pregnancy and the postpartum period?
  3. 3.Is delivery of UCTs via mobile money feasible and acceptable in public ANC clinics in Botswana?
  4. 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)?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
19mo left

Started Mar 2026

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Jan 2028

First Submitted

Initial submission to the registry

November 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

November 3, 2025

Last Update Submit

March 11, 2026

Conditions

Keywords

Cash-transfer

Outcome Measures

Primary Outcomes (5)

  • 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.

    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)

    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)

    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

    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

    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

    At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)

  • Time Preferences (Future Orientation)

    At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)

  • Time Horizon

    At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)

  • Hope

    At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)

  • Stress

    At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3)

  • +7 more secondary outcomes

Study Arms (2)

Cash-Transfer Intervention

EXPERIMENTAL

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

Other: Unconditional Cash Transfer (UCT)

Usual care

NO INTERVENTION

Receives usual care and standard social support

Interventions

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

Cash-Transfer Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lesirane Clinc

Gaborone, Botswana

NOT YET RECRUITING

Mafitlhakgosi Clinic

Gaborone, Botswana

NOT YET RECRUITING

Old Naledi Clinic

Gaborone, Botswana

RECRUITING

Related Publications (6)

  • 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: 6668417BACKGROUND
  • 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: 8636885BACKGROUND
  • Laajaj R. Endogenous time horizon and behavioral poverty trap: Theory and evidence from Mozambique. Journal of Development Economics. 2017;127:187-208.

    BACKGROUND
  • 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.

    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.

    PMID: 28851459BACKGROUND
  • 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.

    BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2025

First Posted

November 10, 2025

Study Start

March 9, 2026

Primary Completion (Estimated)

January 4, 2028

Study Completion (Estimated)

January 4, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Sharing IPD is not part of the study's protocol.

Locations