Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women

Randomized Controlled Trial to Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women in Botswana

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Mothers Moving towards Empowerment (MME)

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana
    • Princess Marina Hospital IDCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mothers Moving towards Empowerment (MME); The MME intervention arm will complete our 8-session intervention, weekly for 60-70 minutes per session. Homework will be assigned each week and reviewed the next session. Certificates will be issued to participants who complete the intervention. Fidelity assessments for each session will be evaluated by local research personnel.	Behavioral: Mothers Moving towards Empowerment (MME); MME integrates 3 components: 1) psychoeducation regarding causes, transmission, and treatment of HIV re how adherence to ART and antenatal care acts to promote health for HIV+ women and PMTCT82,83. We will emphasize ART adherence spanning into PP as a maternal duty to raise a healthy child; 2) challenging stereotypes of HIV+ women, such as promiscuity, that threaten core aspects of being a "good woman" and hinder treatment adherence; 3) coping skills for HIV-related discrimination, i.e., rejection or abandonment by male partners leading to discontinuing treatment adherence and impacts on raising children.
No Intervention: Treatment As Usual (TAU); Control condition participants will receive Treatment as usual (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 MME intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internalized Stigma	Assesses extent HIV stereotypes are applied to the self. 18 items. (scale 0-3). Good reliability & validity	7 minutes
Anticipated Stigma	Assesses extent people living with HIV/AIDS (PLWHA) anticipate rejection if HIV disclosed. 10 items. (scale 0-3) Good reliability & validity	4 minutes
Perceived Community Stigma	Assesses extent community members would devalue PLWHA. 20 items (scale: 0-3) Good reliability & validity	8 minutes
Enacted Stigma	Experienced stigma by PWLHA. 28 items. (scale 0-3). Good reliability & validity	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APGAR Score	Objective: 0-10 as rated by physician (documented at 5 minutes and 10 minutes)	1minute
Pre-term delivery	Objective: Born prior to 37 weeks or 37 weeks and after (Yes/ No). Check hospital record	1minute
Mortality	Objective: Mortality (e.g. neonatal, infant mortality) (Yes/No). Check hospital record	1minute
Birthweight	Objective: Infant weight in grams (low = <2500 g or normal = >2500 g)	1minute
Vaccinations	Objective: from 0-4 visits; Vaccines given at 0, 2, 3, and 4 months (e.g., BCG's, Hep B) (score: 0-3 months)	1minute
Infant HIV status	PCR Assay conducted at 6 weeks and reflected in medical record; (Y/N)	1minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Assessment scale	Self-report scale assessing quality of life. 42 items (scale 0-4). Good reliability & validity.	16 minutes
Depressive Sx-CES-D	Self-report scale assessing depressive symptoms. 20 items (scale 0-3). Good reliability & validity	8 minutes
Social Support	Self-report scale assessing functional social support. 40 items (scale 0-3). Good reliability & validity	16 minutes

Collaborators and Investigators

• Sponsor: New York University
• Investigators: Principal Investigator: Lawrence Yang, Ph.D., New York University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): January 14, 2021
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Stigma
• Other Study ID Numbers: TW011084-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No