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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04846569
• Other study ID #: 1707001841
• Secondary ID: K01MH112443
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Pregnancy Related

Intervention

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.
• 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.

Locations

Country	Name	City	State
South Africa	Gugulethu Community Health Centre	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH), University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Intervention - Number of Counseling Sessions	Feasibility will be assessed through the number of counseling sessions completed.	3 months postpartum
Primary	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
Primary	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
Primary	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	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
Secondary	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