Clinical trial NCT03698981: Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women
Official title: Randomized Controlled Trial to Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women in Botswana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Stigma
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To account for expected drop out (\~10%), \~220 participants will be recruited, resulting in MME and TAU groups of \~100 with complete data by the 56th week following the beginning of pregnancy. For the MME arm, we will enroll 9-10 women per group on a rolling basis to comprise \~12 intervention groups total; \~1 MME group will be initiated per month.
Primary purpose: OTHER

Brief summary: The goal of this proposal is to use a theoretically grounded approach to culturally-tailor a stigma intervention among just identified, pregnant HIV+ women in Botswana. This project will use empirically tested stigma interventions that have shown efficacy for serious mental illness and to adapt these to HIV. Additionally, a novel component of this intervention is the utilization of peers (i.e., mothers with HIV), which has been shown to be an effective stigma reduction agent for other conditions but has not yet been widely used with HIV.

The investigators propose to leverage this middle-income context to conduct a Randomized Controlled Trial (RCT) with HIV+ women (n=100 intervention group, n=100 control group). The investigators examine the stigma intervention for outcomes among mothers (including adherence to Antiretroviral therapy \[ART\] and antenatal treatment), and conduct exploratory birth outcomes among infants (e.g., birth weight, time of delivery) as well. Capacity building activities to transfer stigma intervention knowledge will occur throughout the project to enable investigators in Botswana to independently develop stigma interventions, thus serving as a model for other African countries. Finally, this pilot intervention will provide valuable data for future intervention trials to reduce stigma and improve ART adherence.

Detailed description: To be completed by University of Botswana Research team:

The investigators will sample from the Dept. of Obstetrics and Gynecology (OB/GYN) at Princess Marina Hospital IDCC. Newly-diagnosed pregnant HIV+ women are referred to OB care at Ministry of Health (MOH) antenatal clinics and receive HIV care at the IDCC for continued ART. To account for expected drop out (\~10%), \~220 participants will be recruited. All participants will be randomized to receive MME (the HIV-stigma intervention) or TAU (treatment as usual) from week 28-36 of their pregnancy. The investigators will initiate MME in the antenatal period because the cultural practice of botsetsi (below) could impede implementation post-partum. All participants will have PMTCT by initiation of ART before week 32. Adherence to ART, antenatal and PP care, and viral load testing will be tracked from week 28 of pregnancy to 16 weeks PP (\~week 56 for full-term babies).

Procedures. To account for expected drop out (\~10%), \~220 participants will be recruited, resulting in MME and TAU groups of \~100 with complete data at week 56. For the MME (intervention) arm, the investigators will enroll 9-10 women per group on a rolling basis to comprise \~12 intervention groups total; \~1 MME group will be initiated per month.

Intervention \& Assessment Procedures. One advantage of our study is that, whenever possible, the investigators augment self-report measures with objective measures from medical records (i.e., for infants, birth-weights, APGAR scores at birth; for antenatal treatment, an Antenatal/delivery record tracking antenatal visits that is filled out by doctors; for ART, CD4 count and Viral load data from the integrated patient management system). Fidelity assessments for each session will be evaluated by Ho-Foster. Control Description: Control condition participants will receive TAU, including using free ART and antenatal services as they wish. Control condition participants are assessed on all 'Primary outcomes' at the same time points as the intervention group.

Follow-up Assessment (Months 18-22): Mothers' Postpartum (PP) adherence (56 weeks) serves as a key outcome. The investigators examine a set of exploratory, infant birth outcomes that may result from improved antenatal care and ART adherence. The investigators use an "Under 5 (years old) card" that is filled out by a doctor to track infant's developmental outcomes which is carried by the mother. Child outcomes include: APGAR score, preterm delivery, mortality (at \<16 weeks), birthweight, vaccination record, and mother-to-child-transmission of HIV (MTCT). The investigators will call each participant at 4 months' time and ask to meet in person to review their "Under 5 card" to record infant outcomes at both: a) time of birth; b) 16 weeks PP.

Eligibility criteria: Inclusion Criteria:

* primiparous women
* aged 18 to 45
* diagnosed as HIV+
* receiving care through IDCC with Botswana citizenship
* speak either English or Setswana
* able to provide informed consent

Exclusion Criteria:

* unable to provide informed consent
* non-English or Setswana speakers

Primary outcomes:
measure: Internalized Stigma
timeFrame: 7 minutes
measure: Anticipated Stigma
timeFrame: 4 minutes
measure: Perceived Community Stigma
timeFrame: 8 minutes
measure: Enacted Stigma
timeFrame: 10 minutes
Secondary outcomes:
measure: APGAR Score
timeFrame: 1minute
measure: Pre-term delivery
timeFrame: 1minute
measure: Mortality
timeFrame: 1minute
measure: Birthweight
timeFrame: 1minute
measure: Vaccinations
timeFrame: 1minute
measure: Infant HIV status
timeFrame: 1minute
Other outcomes:
measure: Quality of Life Assessment scale
timeFrame: 16 minutes
measure: Depressive Sx-CES-D
timeFrame: 8 minutes
measure: Social Support
timeFrame: 16 minutes
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital IDCC
Study officials:
affiliation: New York University
name: Lawrence Yang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poku OB, Ho-Foster AR, Entaile P, Misra S, Mehta H, Rampa S, Goodman M, Arscott-Mills T, Eschliman E, Jackson V, Melese T, Becker TD, Eisenberg M, Link B, Go V, Opondo PR, Blank MB, Yang LH. 'Mothers moving towards empowerment' intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial. Trials. 2020 Oct 7;21(1):832. doi: 10.1186/s13063-020-04676-6.