Postpartum Adherence Clubs to Enhance Support: the PACER Study

NACompletedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
HIV
Interventions
OTHER

Community-based Adherence Clubs

"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."

OTHER

Standard of Care for Mothers

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.

OTHER

Standard of Care for Infants

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.

Trial Locations (1)

Unknown

Gugulethu Community Health Centre, Cape Town

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Columbia University

OTHER

NCT02417675 - Postpartum Adherence Clubs to Enhance Support: the PACER Study | Biotech Hunter | Biotech Hunter