Clinical trial NCT03200054: Postpartum Adherence Clubs for Antiretroviral Therapy
Official title: Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: therapy
postnatal
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2017-06-27
Enrollment: 412
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Viral suppression
timeFrame: 24 months
Secondary outcomes:
measure: Maternal retention in care
timeFrame: 24 months
measure: Maternal death
timeFrame: 24 months
measure: Maternal mental health
timeFrame: 24 months
measure: Maternal health care service use
timeFrame: 24 months
measure: Infant death
timeFrame: 24 months
measure: Infant health care service use
timeFrame: 24 months
measure: Infant HIV testing
timeFrame: 24 months
measure: Infant HIV infection
timeFrame: 24 months
measure: Infant feeding
timeFrame: 24 months
measure: Cost and cost-effectiveness
timeFrame: 24 months
measure: Acceptability of each ART service
timeFrame: 24 months
measure: Viral suppression at other cutpoints (>400 copies/mL)
timeFrame: 24 months
measure: Viral suppression at other cutpoints (>50 copies/mL)
timeFrame: 24 months
measure: Virologic Failure
timeFrame: 24 months
measure: Combined retention/VL outcome
timeFrame: 24 months
measure: Viral suppression at each study visit
timeFrame: 24 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Landon Myer, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.