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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic-based Care | No Intervention | 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. | |
| Adherence Club Care | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherence Clubs | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Viral suppression | Time to viral load >1000 copies per ml | 24 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Landon Myer, MBChB PhD | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gugulethu Community Health Centre | Cape Town | Western Cape | 7750 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18670232 | Background | 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. | |
| 22951634 | Background | 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. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| 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 |
| 23351797 | Background | 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. |
| 23440538 | Background | 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. |
| 23418518 | Background | 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. |
| Background | Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |