Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 4K23MH131464-04 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Botswana | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cash-Transfer Intervention | Experimental | Receives usual care and Unconditional Cash Transfers (UCTs) of 1,000 BWP/month |
|
| Usual care | No Intervention | Receives usual care and standard social support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unconditional Cash Transfer (UCT) | Other | Unconditional Cash Transfer (UCT) of 1,000 BWP/month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) |
| Time Preferences (Future Orientation) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaron G Richterman, MD, MPH | Contact | 267-441-7915 | Aaron.Richterman@Pennmedicine.upenn.edu | |
| Charlotte N Babbin, BA | Contact | 2039151038 | charlotte.babbin@pennmedicine.upenn.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lesirane Clinc | Not yet recruiting | Gaborone | Botswana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6668417 | Background | 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. | |
| 8636885 | 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. |
Not provided
Not provided
Sharing IPD is not part of the study's protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) |
| At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) |
| Time Horizon | Time Horizon (Laajaj) - length of time finances are planned in advance | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) |
| Hope | State Hope Scale, 8-item scale - self-report measure of goal directed thinking, values 1-8, higher value indicates greater hope | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) |
| Stress | Perceived Stress Scale-4, 5-item scale (assessment of perceived stress over the past 30 days), values 1-5 | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) |
| Psychological Distress | Kessler 6+ (assessment of frequency of psychological distress symptoms over the past 30 days), values 1-5, higher value indicates greater distress | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) |
| Pregnancy status: pregnant or post-partum | Self-reported status of pregnancy (pregnant or post-partum) | At baseline visit, gestational age ≥ 30 weeks (visit 2), 3-6 months post-partum (visit 3) |
| Location of delivery | Collected from the electronic health record database: whether participant gave birth at a health facility, home, or other | At 3-6 months post-partum (visit 3) |
| Gestational age at delivery | Gestational age at delivery, collected from electronic health record database | At 3-6 months post-partum (visit 3) |
| Birth outcome | Collected from electronic health record database: live birth (child is alive), live birth (child is deceased), still birth, miscarriage, or other | 3-6 months post-partum (visit 3) |
| Antenatal HIV clinic attendance | From electronic health record database: number of attended visits, number of scheduled visits | From baseline visit through 6 months post-partum |
| Post-partum HIV clinic attendance | From electronic health record database: number of attended visits, number of scheduled visits | From baseline visit through 6 months post-partum |
| Mafitlhakgosi Clinic | Not yet recruiting | Gaborone | Botswana |
|
| Old Naledi Clinic | Recruiting | Gaborone | Botswana |
|
| Background | 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. |
| 28851459 | 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. |
| Background | 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. |