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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Pregnancy Related
• Intervention / Treatment: Behavioral: Transition Theory-based Intervention; Behavioral: Enhanced Standard of Care Control

Detailed Description

Prevention of mother-to-child transmission (PMTCT) efforts have reduced the rates of vertical transmission to 2.7%, however, optimal antiretroviral therapy (ART) adherence remains a difficult goal to reach, particularly postpartum. Longitudinal qualitative research reveals a variety of facilitators and barriers to the transition from pregnancy to postpartum including employment/financial concerns, logistical concerns around childcare and breastfeeding, worries about vertical transmission and difficulties bonding. This intervention draws on the growing cadre of community health workers within the South African health care system and Transition Theory to develop a behavioral intervention to support women living with HIV through the transition from pregnancy to postpartum. The investigators are conducting a small scale pilot study to compare the impact of a Transition Theory-based intervention to enhanced standard of care on self-reported ART adherence and engagement in ART services among pregnant and postpartum women living with HIV.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Gugulethu Community Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18 years of age or older
2. HIV positive status (based on clinic records)
3. Confirmed pregnant (based on clinic records) and estimated to be 23-34 weeks gestation (clinic records or self-report)
4. Currently prescribed ART
5. Planning on remaining a resident of Cape Town for at least 6 months postpartum
6. Ability to speak isiXhosa or English
7. Able to provide informed consent

Exclusion Criteria:

• Failure to meet any of the inclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transition Theory-based Intervention; 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; 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.
Active Comparator: Enhanced Standard of Care Control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability/Utility of the Intervention	Acceptability of the Transition Theory-based intervention, assessed during in-depth interviews among participants in the intervention condition to gauge general feelings of acceptability and perceived usefulness of the intervention.	6 months postpartum
Adherence Self-efficacy - Confidence in Taking Medications	Adherence self-efficacy will be measured using the AACTG adherence self-efficacy scale, 15 items, using 5 point Likert scale ranging from not confident at all to very confident. Total scores range from 15-75, with higher scores indicating higher self-efficacy.	6 months postpartum

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute of Mental Health (NIMH); University of Cape Town
• Investigators: Principal Investigator: Jennifer A Pellowski, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Pregnancy; Postpartum; South Africa
• Other Study ID Numbers: 1707001841; K01MH112443 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified datasets will be made available by request, subject to agreement to Access Criteria, see below
• IPD Sharing Time Frame: After primary data has been published (anticipated September 2022), by request
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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