Hiv
Conditions
Keywords
therapy, postnatal
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.
Interventions
OTHERAdherence 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.
Sponsors
Medical Research Council
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression | 24 months | Time to viral load \>1000 copies per ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal death | 24 months | Maternal deaths over the study period |
| Maternal mental health | 24 months | Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale) |
| Maternal health care service use | 24 months | Use of health facilities including hospitalization |
| Infant death | 24 months | Infant deaths over the study period |
| Infant health care service use | 24 months | Use of health facilities including hospitalization |
| Infant HIV testing | 24 months | Uptake of routine infant HIV testing |
| Infant HIV infection | 24 months | Mother-to-child transmission of HIV |
| Maternal retention in care | 24 months | Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit) |
| Cost and cost-effectiveness | 24 months | Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective |
| Acceptability of each ART service | 24 months | Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants |
| Viral suppression at other cutpoints (>400 copies/mL) | 24 months | Time to VL \>400 copies/mL |
| Viral suppression at other cutpoints (>50 copies/mL) | 24 months | Time to VL \>50 copies/mL |
| Virologic Failure | 24 months | Time to clinical definition of virologic failure (two consecutive VLs \>1000 copies/mL) |
| Combined retention/VL outcome | 24 months | Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL \>50 or 1000 copies/mL) |
| Viral suppression at each study visit | 24 months | VL \>50 copies/mL or \>1000 copies/mL at each study visit (3, 6, 12, 18, 24 months) |
| Infant feeding | 24 months | Breastfeeding practices |
Countries
South Africa
Outcome results
None listed