Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1050 participants
INTERVENTIONAL
2013-11-30
2016-08-31
Brief Summary
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Detailed Description
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Although the Option B Plus strategy offers an attractive rapid ART scale-up alternative to the WHO PMTCT recommendations and has the potential to profoundly impact maternal and infant outcomes, it has not been implemented in any programme setting. Operational challenges throughout the cascade of PMTCT services may affect the uptake and adherence to highly active ART treatment (HAART) by pregnant women, the follow-up of HIV-exposed infants and the long-term retention of this patient population. Several issues identified at the national level are potential threats to the successful implementation and scale up of Option B plus: a) potential suboptimal uptake of HAART by asymptomatic pregnant women due to low treatment literacy and stigma; b) low adherence to HAART and poor follow-up of HIV exposed infants; and c) lack of psycho-social support for long term retention in this relatively asymptomatic patient population (Schouten et al. 2011).
The aim of the overall project (4 years) is to evaluate facility-based and community-based support models to strengthen uptake and retention of mothers and families in PMTCT care in Malawi. Our hypothesis is that enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.
We will conduct a cluster randomized clinical trial evaluating three support models for the implementation of the Option B+ program. Each of the 21 clinics will be randomized to one of the three adherence and support strategies. Arm 1 is the standard of care arm as outlined by the Ministry of Health, Arm 2 is facility level support by a peer educator and Arm 3 is community level support by a peer educator.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Facility-based Peer Support
Facility-based Peer Support to provide the following at the clinic
* Routine standard clinical care based on the MoH guidelines
* Mentor mothers provide education and psychosocial support at facility
* Weekly support groups provided in clinic
* Phone call, SMS, or home visit for each missed appointment
Facility-based Peer Support
Facility-based Peer Support to provide the following at the clinic
Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support at facility Weekly support groups provided in clinic Phone call, SMS, or home visit for each missed appointment
Community-based Peer Support
Community-based Support from Peer Mothers (Expert mothers):
* Routine standard clinical care based on the MoH guidelines
* Mentor mothers provide education and psychosocial support in community prior to each visit
* Monthly support groups in community
* Home visits for each missed appointment
Community based peer support
Community-based Support from Peer Mothers (Expert mothers):
Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support in community prior to each visit Monthly support groups in community Home visits for each missed appointment
Standard of Care
The Standard of care as outlined in the Malawi HIV integrated Care Guidelines
No interventions assigned to this group
Interventions
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Community based peer support
Community-based Support from Peer Mothers (Expert mothers):
Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support in community prior to each visit Monthly support groups in community Home visits for each missed appointment
Facility-based Peer Support
Facility-based Peer Support to provide the following at the clinic
Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support at facility Weekly support groups provided in clinic Phone call, SMS, or home visit for each missed appointment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
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World Health Organization
OTHER
AIDS Fonds
OTHER
Mothers2Mothers
UNKNOWN
Kamuzu University of Health Sciences
OTHER
Management Sciences for Health
OTHER
Dignitas International
OTHER
University of North Carolina, Chapel Hill
OTHER
University of Malawi
OTHER
Ministry of Health and Population, Malawi
OTHER_GOV
Lighthouse Trust
OTHER
Responsible Party
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Sam Phiri, PhD, MSc, DCM
Executive Director
Principal Investigators
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Sam Phiri, PhD, MSc.
Role: PRINCIPAL_INVESTIGATOR
Lighthouse Trust
Locations
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Ministry of Health Facilities
Lilongwe, , Malawi
Countries
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Central Contacts
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References
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van Lettow M, Tweya H, Rosenberg NE, Trapence C, Kayoyo V, Kasende F, Kaunda B, Hosseinipour MC, Eliya M, Cataldo F, Gugsa S, Phiri S; PURE Malawi consortium. Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi. Reprod Health. 2017 Jul 11;14(1):82. doi: 10.1186/s12978-017-0343-0.
Cataldo F, Sam-Agudu NA, Phiri S, Shumba B, Cornelius LJ, Foster G. The Roles of Expert Mothers Engaged in Prevention of Mother-to-Child Transmission (PMTCT) Programs: A Commentary on the INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S224-S232. doi: 10.1097/QAI.0000000000001375.
Hosseinipour M, Nelson JAE, Trapence C, Rutstein SE, Kasende F, Kayoyo V, Kaunda-Khangamwa B, Compliment K, Stanley C, Cataldo F, van Lettow M, Rosenberg NE, Tweya H, Gugsa S, Sampathkumar V, Schouten E, Eliya M, Chimbwandira F, Chiwaula L, Kapito-Tembo A, Phiri S; PURE Malawi Consortium. Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2(Suppl 2):S149-S155. doi: 10.1097/QAI.0000000000001368.
Phiri S, Tweya H, van Lettow M, Rosenberg NE, Trapence C, Kapito-Tembo A, Kaunda-Khangamwa B, Kasende F, Kayoyo V, Cataldo F, Stanley C, Gugsa S, Sampathkumar V, Schouten E, Chiwaula L, Eliya M, Chimbwandira F, Hosseinipour MC; PURE Malawi Consortium. Impact of Facility- and Community-Based Peer Support Models on Maternal Uptake and Retention in Malawi's Option B+ HIV Prevention of Mother-to-Child Transmission Program: A 3-Arm Cluster Randomized Controlled Trial (PURE Malawi). J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S140-S148. doi: 10.1097/QAI.0000000000001357.
Cataldo F, Chiwaula L, Nkhata M, van Lettow M, Kasende F, Rosenberg NE, Tweya H, Sampathkumar V, Hosseinipour M, Schouten E, Kapito-Tembo A, Eliya M, Chimbwandira F, Phiri S; PURE Malawi Consortium. Exploring the Experiences of Women and Health Care Workers in the Context of PMTCT Option B Plus in Malawi. J Acquir Immune Defic Syndr. 2017 Apr 15;74(5):517-522. doi: 10.1097/QAI.0000000000001273.
Chiwaula LS, Chirwa GC, Cataldo F, Kapito-Tembo A, Hosseinipour MC, van Lettow M, Tweya H, Kayoyo V, Khangamwa-Kaunda B, Kasende F, Trapence C, Gugsa S, Rosenberg NE, Eliya M, Phiri S; PURE Malawi Consortium. The value of informal care in the context of option B+ in Malawi: a contingent valuation approach. BMC Health Serv Res. 2016 Apr 19;16:136. doi: 10.1186/s12913-016-1381-y.
Other Identifiers
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PUREMalawi
Identifier Type: -
Identifier Source: org_study_id