Clinical trial NCT02417675: Postpartum Adherence Clubs to Enhance Support: the PACER Study
Official title: Postpartum Adherence Clubs to Enhance Support: the PACER Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Option B+
Adherence Club
Postpartum
Breastfeeding
Mother-to-child transmission
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-04-16
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Western Cape province of South Africa (SA) is changing the way it treats pregnant women with HIV. Now, all HIV-infected pregnant women, regardless of how sick or healthy they are, will receive antiretroviral treatment (ART) for life ("Option B+"). However, there are few well-developed models of service delivery to support this change to "Option B+" in the Western Cape and many parts of the continent.

The parent study -- Strategies to Optimize ART Services for Maternal \& Child Health (MCH-ART)-- is testing two clinic-based models of service delivery for Option B+ . To complement MCH-ART, this study, PACER, will test whether community-based Adherence Clubs are an effective model for keeping breastfeeding women in HIV care after pregnancy. These clubs have been used to free up space at ART clinics by moving stable HIV+ patients to community-based services, but they have not been studied as an effective strategy among breastfeeding women after delivery. PACER seeks to address this gap.

Detailed description: The Western Cape province of South Africa (SA) is implementing the policy of universal initiation of lifelong ART in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). However there are few well-developed models of service delivery to support implementation of "Option B+" in the Western Cape and many parts of the continent. In particular, while systems for initiation and follow-up of pregnant women on ART are based within well-established antenatal care clinics (ANC), there are major concerns regarding delivery of ART to HIV-infected women during the postpartum period. Multiple studies indicate high levels of non-retention in care, and/or inadequate ART adherence, during the postpartum period, presenting a threat to HIV-infected women and their infants.4-8 In turn, there is an urgent need for evidence-based approaches to support the growing number of HIV-infected mothers on ART.

In this context, the parent study-- Strategies to Optimize ART Services for Maternal \& Child Health (MCH-ART)-- provides a rigorous implementation science framework for understanding optimal approaches for managing HIV-infected women and their HIV-exposed infants in the first year after delivery under "Option B+". While MCH-ART focuses on clinic-based models of care, there is also growing attention to the role of community health workers (CHWs) in supporting patients on ART, including community-based distribution and adherence support away from health facilities.To complement MCH-ART, the PACER study aims to investigate community-based Adherence Clubs as an effective model for engaging and retaining breastfeeding women beyond pregnancy to maximize maternal and infant health. In Cape Town, specifically, Adherence Clubs have been developed in which ART services are located away from clinics and are led by CHWs with support from ART clinic nurses. These clubs have been implemented to help decongest ART clinics by shifting stable patients to community-based services, but they have not been studied as an effective strategy among breastfeeding women in the postpartum period. PACER seeks to address this gap by randomizing women in the parent study, MCH-ART, to either the AC system or to the nearest adult ART clinic. Infants in both arms will receive the same services, following the local standard of care.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Documented HIV-infection according to two finger-prick rapid tests using different test types (per routine protocol in this setting) or documentation of HIV status for those women self reporting HIV diagnosis.
* Initiated ART during the antenatal period (during most recent pregnancy)
* Within one month postpartum
* Currently breastfeeding within one month postpartum
* Willingness to return for postnatal study visits
* Able to provide informed consent for research
* Eligible to receive care at local Adherence Club, based on following local eligibility criteria:

  1. Virally suppressed (HIV RNA \<1000 copies/mL) per most recent viral load test (conducted during pregnancy)
  2. Clinically stable (no active co-morbidity including opportunistic infections)
  3. Current resident of a catchment area appropriate for Adherence Club referral
* Infants of women enrolled in the study.

Exclusion Criteria:

* Receipt of any ART services outside the Gugulethu MOU ART service in the postpartum period
* Intention to relocate out of Cape Town permanently during the following one year
* Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study, including:

  1. Refusal to take ART/ARVs
  2. Denial of HIV status

Primary outcomes:
measure: Maternal retention
timeFrame: 12 months
Secondary outcomes:
measure: Maternal Loss to Follow-up
timeFrame: 12 months
measure: Maternal Viral Suppression
timeFrame: 12 months
measure: Infant HIV diagnosis
timeFrame: 12 months
measure: Infant vaccination
timeFrame: 12 months
measure: Mother-to-child transmission
timeFrame: 12 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
state: Western Cape
Study officials:
affiliation: ICAP at Columbia University
name: Elaine J Abrams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Landon Myer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zerbe A, Brittain K, Phillips TK, Iyun VO, Allerton J, Nofemela A, Kalombo CD, Myer L, Abrams EJ. Community-based adherence clubs for postpartum women on antiretroviral therapy (ART) in Cape Town, South Africa: a pilot study. BMC Health Serv Res. 2020 Jul 8;20(1):621. doi: 10.1186/s12913-020-05470-5.
citation: Trafford Z, Gomba Y, Colvin CJ, Iyun VO, Phillips TK, Brittain K, Myer L, Abrams EJ, Zerbe A. Experiences of HIV-positive postpartum women and health workers involved with community-based antiretroviral therapy adherence clubs in Cape Town, South Africa. BMC Public Health. 2018 Jul 31;18(1):935. doi: 10.1186/s12889-018-5836-4.