Clinical trial NCT04846569: Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
Official title: Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Pregnancy Related
Keywords: HIV
Pregnancy
Postpartum
South Africa
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: National Institute of Mental Health (NIMH)
First posted: 2021-04-15
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Intervention - Number of Counseling Sessions
timeFrame: 3 months postpartum
measure: Preliminary Efficacy - ART Adherence
timeFrame: 6 months postpartum
measure: Preliminary Efficacy- Retention in HIV Services
timeFrame: 6 months postpartum
measure: Preliminary Efficacy-viral Suppression
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Adherence Self-efficacy - Confidence in Taking Medications
timeFrame: 6 months postpartum
measure: Acceptability/Utility of the Intervention
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
Study officials:
affiliation: Brown University
name: Jennifer A Pellowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: