Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)

Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial

South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Other: Adherence Clubs

Detailed Description

South Africa 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+") and given the high antenatal HIV seroprevalence, HIV-infected pregnant women represent the largest group of patients initiating ART in primary care facilities. However, there are few well developed models of service delivery to support implementation. There are particular concerns regarding the postpartum period, with multiple studies indicating high levels of non-retention in care and/or inadequate adherence to treatment postnatally. Adherence Clubs (ACs) are an innovative but untested model of care based on chronic disease management strategies that emphasize social support, adherence to treatment and retention in care, rather than intensive clinical management, as the most important determinant of long-term health outcomes in stable patients in chronic care. ACs have preliminarily been shown to to result in virologic outcomes that are similar to routine clinic services in patients stable on ART. The investigators are conducting a pragmatic, randomised controlled trial to evaluate two different strategies for delivering HIV care and treatment services during the postpartum period to HIV-infected women who initiated ART during pregnancy. Participants will be allocated to receive ART care at either local adult ART clinics, following the current standard of care, or the community-based adherence club system.

• Study Type: Interventional
• Enrollment (Actual): 412
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7750
      • Gugulethu Community Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Documented HIV infection with ART initiation during the preceding antenatal period
• Within 70 days post-delivery
• Viral suppression documented in pregnancy with the most recent viral load <400 copies/mL within the last 3 months
• Willingness to be randomised and return for study measurement visits
• Able and willing to attend service visits at either a local ART treatment centre or the adherence club at Ikhwezi centre
• Able to provide informed consent for research

Exclusion Criteria:

• Intention to relocate out of Cape Town permanently during the study period
• 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/antiretrovirals (ARVs) and/or denial of HIV status
• Loss of pregnancy/neonate at the time of eligibility determination
• Current co-morbidity requiring additional health care attention, including opportunistic infections such as tuberculosis (TB) disease or any chronic condition or other condition that is not controlled or stable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Clinic-based Care; Clinic-based care is the current standard of care and is defined as referral of women on antiretroviral therapy (ART) to general primary care adult ART services.
Experimental: Adherence Club Care; Adherence club care involves referral of women on ART to community-based ART services in the form of adherence clubs, which are led by community health workers and supported by ART clinic nurses.	Other: Adherence Clubs; Women will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC). AC visits occur 2-4 monthly at a community hall near the CHC. At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART. Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse. A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit. Participants requiring more regular follow-up and those with raised viral loads are referred back to the ART clinic at the CHC by the nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral suppression	Time to viral load >1000 copies per ml	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal retention in care	Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)	24 months
Maternal death	Maternal deaths over the study period	24 months
Maternal mental health	Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)	24 months
Maternal health care service use	Use of health facilities including hospitalization	24 months
Infant death	Infant deaths over the study period	24 months
Infant health care service use	Use of health facilities including hospitalization	24 months
Infant HIV testing	Uptake of routine infant HIV testing	24 months
Infant HIV infection	Mother-to-child transmission of HIV	24 months
Infant feeding	Breastfeeding practices	24 months
Cost and cost-effectiveness	Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective	24 months
Acceptability of each ART service	Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants	24 months
Viral suppression at other cutpoints (>400 copies/mL)	Time to VL >400 copies/mL	24 months
Viral suppression at other cutpoints (>50 copies/mL)	Time to VL >50 copies/mL	24 months
Virologic Failure	Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)	24 months
Combined retention/VL outcome	Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)	24 months
Viral suppression at each study visit	VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)	24 months

Collaborators and Investigators

• Sponsor: University of Cape Town
• Collaborators: Medical Research Council
• Investigators: Principal Investigator: Landon Myer, MBChB PhD, University of Cape Town

Publications and helpful links

General Publications

• Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.
• Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f.
• Kaplan R, Orrell C, Zwane E, Bekker LG, Wood R. Loss to follow-up and mortality among pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 2008 Aug 20;22(13):1679-81. doi: 10.1097/QAD.0b013e32830ebcee.
• Coutsoudis A, Goga A, Desmond C, Barron P, Black V, Coovadia H. Is Option B+ the best choice? Lancet. 2013 Jan 26;381(9863):269-71. doi: 10.1016/S0140-6736(12)61807-8. No abstract available.
• Chi BH, Stringer JS, Moodley D. Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep. 2013 Jun;10(2):124-33. doi: 10.1007/s11904-013-0154-z.
• Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: therapy; postnatal
• Other Study ID Numbers: 195/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO