Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa

NCT04846569 | Completed Results

• 2 other identifiers: 1707001841K01MH112443
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Despite high levels of adherence motivation during pregnancy, HIV treatment adherence and engagement in care is difficult for women in the postpartum period. Supporting women during the transition from pregnancy to postpartum is imperative to sustaining HIV treatment adherence during this period. The investigators are conducting a small scale pilot study of a behavioral Transition Theory-based intervention to support ART adherence and engagement in ART services among pregnant and postpartum women living with HIV.

Conditions

HIV; Pregnancy Related

Keywords

HIV; Pregnancy; Postpartum; South Africa

Outcome Measures

Primary Outcomes (4)

• Feasibility of the Intervention - Number of Counseling Sessions

  Feasibility will be assessed through the number of counseling sessions completed.

  3 months postpartum

• Preliminary Efficacy - ART Adherence

  Preliminary efficacy will be assessed as the correlation between study arm and self-reported HIV adherence on the 3 item Wilson ART adherence scale (self-report, 3 item scale recoded as 0-100, 100 indicating perfect adherence in the past month) at 6 months postpartum.

  6 months postpartum

• Preliminary Efficacy- Retention in HIV Services

  Preliminary efficacy will be assessed as the correlation between study arm and retention in HIV services at 6 months postpartum. Retention in HIV services is measured by clinic records. Retention at 6 months postpartum is measured as attended HIV clinic appointment in the past 3 months.

  6 months postpartum

• Preliminary Efficacy-viral Suppression

  Preliminary efficacy will be assessed as the correlation between study arm and viral suppression at 6 months postpartum. Viral suppression will be measured by clinic records, with viral suppression defined as HIV viral load less than 200 copies/mL.

  6 months postpartum

Secondary Outcomes (2)

• Adherence Self-efficacy - Confidence in Taking Medications

  6 months postpartum

• Acceptability/Utility of the Intervention

  6 months postpartum

Study Arms (2)

Transition Theory-based Intervention

EXPERIMENTAL

Participants in the intervention arm will receive the Transition Theory-based intervention consisting of 4 sessions with a community health worker (2 during pregnancy, 2 postpartum) to support their transition from pregnancy to postpartum.

Behavioral: Transition Theory-based Intervention

Enhanced Standard of Care Control

ACTIVE COMPARATOR

Participants in the control arm will receive the standard of care plus one session with a community health worker.

Behavioral: Enhanced Standard of Care Control

Interventions

Transition Theory-based Intervention BEHAVIORAL

The behavioral intervention is a theoretically driven curriculum focused on supporting mothers from pregnancy through postpartum in order to promote sustained HIV treatment adherence. Sessions utilize motivational interviewing and consist of a range of topics including motherhood, preparing for baby, disclosure, HIV education, adherence, birth experiences, support systems, and living positively.

Transition Theory-based Intervention

Enhanced Standard of Care Control BEHAVIORAL

In addition to standard of care, participants receive the first session of the Transition Theory-based Intervention curriculum which focuses on motherhood and preparation for baby but does not discuss the transition from pregnancy to postpartum or the postpartum period.

Enhanced Standard of Care Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We will enroll only pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• HIV positive status (based on clinic records)
• Confirmed pregnant (based on clinic records) and estimated to be 23-34 weeks gestation (clinic records or self-report)
• Currently prescribed ART
• Planning on remaining a resident of Cape Town for at least 6 months postpartum
• Ability to speak isiXhosa or English
• Able to provide informed consent

You may not qualify if:

• Significant pre-existing psychiatric comorbidity at enrolment that may impact ability to consent according to the judgement of study personnel (including cognitive impairment or known psychotic disorder) Note: mothers will not be withdrawn from the study following foetal complications or death

Sponsors & Collaborators

• Brown University: lead
• University of Cape Town: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, South Africa

Location

Results Point of Contact

• Title: Jennifer Pellowski
• Organization: Brown University

jennifer_pellowski@brown.edu

4018635453

Study Officials

• Jennifer A Pellowski, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 15, 2021
• Study Start: April 12, 2021
• Primary Completion: December 30, 2022
• Study Completion: September 30, 2023
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After primary data has been published (anticipated September 2022), by request
• Access Criteria: (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology and established security measures; (3) a plan for the dissemination of results; (4) appropriate authorship and recognition of all partners; and (5) a commitment to destroy or return the data after analyses are completed.

Locations

ZA (1)