Postpartum Adherence Clubs for Antiretroviral Therapy

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial

Conditions
-----------------
Hiv

Intervention / Treatment
-----------------
* Other: Adherence Clubs


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Clinic-based Care<br>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<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
therapy, postnatal