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Completed

NCT Number: NCT04846569

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.

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Key information

Conditions

HIV Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gugulethu Community Health Centre

Cape Town, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility of the Intervention - Number of Counseling Sessions

    Time frame: 3 months postpartum

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

  2. Preliminary Efficacy - ART Adherence

    Time frame: 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.

  3. Preliminary Efficacy- Retention in HIV Services

    Time frame: 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.

  4. Preliminary Efficacy-viral Suppression

    Time frame: 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 outcomes

  1. Adherence Self-efficacy - Confidence in Taking Medications

    Time frame: 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.

  2. Acceptability/Utility of the Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Cape Town

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 15, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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