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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV, Pregnancy Related

Intervention / Treatment
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* Behavioral: Transition Theory-based Intervention
* Behavioral: Enhanced Standard of Care Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transition Theory-based Intervention<br>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<br>* 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.<br>|
| Active Comparator: Enhanced Standard of Care Control<br>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<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Pregnancy, Postpartum, South Africa