Reduce Stigma and Improve Treatment Adherence in HIV+ Pregnant Women

NCT03698981 | Completed DMC

• 1 other identifier: TW011084-01
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Stigma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• APGAR Score

  1minute

• Pre-term delivery

  1minute

• Mortality

  1minute

• Birthweight

  1minute

• Vaccinations

  1minute

Other Outcomes (3)

• Quality of Life Assessment scale

  16 minutes

• Depressive Sx-CES-D

  8 minutes

• Social Support

  16 minutes

Study Arms (2)

Mothers Moving towards Empowerment (MME)

EXPERIMENTAL

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)

Treatment As Usual (TAU)

NO INTERVENTION

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.

Interventions

Mothers Moving towards Empowerment (MME) BEHAVIORAL

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.

Mothers Moving towards Empowerment (MME)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: All participants must be Primiparous women diagnosed as HIV+ receiving both antenatal care and ART.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

Princess Marina Hospital IDCC

Gaborone, Botswana

Location

Related Publications (1)

• 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.

  PMID: 33028387 DERIVED

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Lawrence Yang, Ph.D.

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff conducting "primary outcome measures" with mothers at baseline, post-intervention, and week 56 (in person) will be blinded to treatment assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: October 9, 2018
• Study Start: March 15, 2019
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)