Postpartum Adherence Clubs to Enhance Support: the PACER Study

NCT02417675 | Completed DMC

• 2 other identifiers: AAAO56013R01HD074558-03S1
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Option B+; Adherence Club; Postpartum; Breastfeeding; Mother-to-child transmission

Outcome Measures

Primary Outcomes (1)

• Maternal retention

  Proportion of mothers retained in HIV care and adhering to ART at 12 months postpartum

  12 months

Secondary Outcomes (5)

• Maternal Loss to Follow-up

  12 months

• Maternal Viral Suppression

  12 months

• Infant HIV diagnosis

  12 months

• Infant vaccination

  12 months

• Mother-to-child transmission

  12 months

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

Women who choose the SOC will receive postpartum antiretroviral therapy (ART) services at their nearest primary care clinic, following the Standard of Care for Mothers. Details are provided in the intervention description. Infants receive the same care in each arm, according to the Standard of Care for Infants.

Other: Standard of Care for Mothers; Other: Standard of Care for Infants

Intervention (AC)

EXPERIMENTAL

Women who choose the Community-based Adherence Clubs (AC) will receive postpartum antiretroviral therapy (ART) services at an AC, rather than at their nearest primary care clinic as in the SOC arm. Details are provided in the intervention section. Infants receive the same care in each arm, according to the Standard of Care for Infants.

Other: Community-based Adherence Clubs; Other: Standard of Care for Infants

Interventions

Community-based Adherence Clubs OTHER

Women in the AC arm are prescribed 2 months of their current ART medication (compared to 1 month in the SOC) and will be advised to go to the AC office immediately, where they will be scheduled for their first session. Women will attend AC meetings every two months. At these meetings, women will receive a 2 month supply of medication, health education and peer-support. A trained Community Health Worker (CHW) will also collect blood samples, weight, and current signs/symptoms from women. Each participant has 5 working days after their AC session to come and collect her medication. Those who have defaulted will be followed up by the CHW via phone calls and, possibly, home visits. If reached, women will be told to return immediately to the main ART facility for receipt of ART care.

Also known as: AC

Intervention (AC)

Standard of Care for Mothers OTHER

Women will be referred immediately from the maternity ART clinic to their nearest adult ART clinic at their first postpartum clinic visit. At referral, they receive an initial 1-month supply of their current ART medication. At the first appointment after transfer into the general ART service, patients undergo clinical history and examination by a doctor or clinical nurse practitioner. Laboratory investigations are ordered according to standard protocols or based on clinician discretion. For the 1st 4 months in the new service, stable patients are dispensed 1 month of ART; subsequent visits are 2-monthly for medication refill, with clinician review 6-monthly; patients with particular clinical or psychosocial concerns may be reviewed more regularly, or referred to higher levels of care.

Also known as: SOC

Standard of Care (SOC)

Standard of Care for Infants OTHER

All infants will receive care at their nearest primary care clinic. Following national protocols, all HIV-infected mothers are issued a 6-week supply of nevirapine syrup after delivery and counselled on daily nevirapine prophylaxis. Infant follow-up takes place within 1 week postpartum with the mother (at the MOU) and then at 6 weeks postpartum (at the nearest primary care clinic) when HIV PCR testing of the infant is carried out. Following national protocols, infants who are breastfed beyond 6 weeks receive HIV PCR testing 2-4 weeks after the cessation of breastfeeding, again conducted at the nearest City of Cape Town primary care clinic.

Intervention (AC); Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Refusal to take ART/ARVs
• Denial of HIV status

Sponsors & Collaborators

• Columbia University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, Western Cape, South Africa

Location

Related Publications (2)

• 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.

  PMID: 32641032 DERIVED

• 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.

  PMID: 30064405 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elaine J Abrams, MD

  ICAP at Columbia University

  PRINCIPAL INVESTIGATOR

• Landon Myer, MD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Director, ICAP

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 16, 2015
• Study Start: February 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

ZA (1)