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

Not Applicable

Completed

Interventions: Behavioral: Transition Theory-based Intervention
Behavioral: Enhanced Standard of Care Control

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Transition Theory-based Intervention	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.
Enhanced Standard of Care Control	Enhanced Standard of Care Control	Participants in the control arm will receive the standard of care plus one session with a community health worker.

Primary Outcome Measures

Name	Time	Method
Feasibility of the Intervention - Number of Counseling Sessions	3 months postpartum	Feasibility will be assessed through the number of counseling sessions completed.
Preliminary Efficacy - ART Adherence	6 months postpartum	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.
Preliminary Efficacy- Retention in HIV Services	6 months postpartum	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.
Preliminary Efficacy-viral Suppression	6 months postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Adherence Self-efficacy - Confidence in Taking Medications	6 months postpartum	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.
Acceptability/Utility of the Intervention	6 months postpartum	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.