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

Brown University

Status: Completed

Conditions: HIV; Pregnancy Related

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04846569

1707001841

K01MH112443 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Transition Theory-based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Transition Theory-based Intervention

Enhanced Standard of Care Control

Active Comparator group

Description:

Participants in the control arm will receive the standard of care plus one session with a community health worker.

Treatment:

Behavioral: Enhanced Standard of Care Control