NCT02005835

Brief Summary

The purpose of this study is to determine if 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

1.5 years

First QC Date

December 4, 2013

Last Update Submit

December 4, 2013

Conditions

HIV

Keywords

HIVOption B+Prevention of Mother to Child Transmission

Outcome Measures

Primary Outcomes (1)

  • Retention in Care

    The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.

    12 months post ART initiation

Secondary Outcomes (8)

  • Retention at 24 months

    24 months post ART initiation

  • Child HIV status

    6 weeks, 12 months, 24 months

  • HIV free survival

    6 weeks, 12 months, 24 months

  • Family retention

    12 months

  • Maternal Viral Load

    6 months and 2 years post ART initiation

  • +3 more secondary outcomes

Other Outcomes (1)

  • Economics

    baseline, 12, 24 months

Study Arms (3)

Facility-based Peer Support

OTHER

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

Other: Facility-based Peer Support

Community-based Peer Support

OTHER

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

Other: Community based peer support

Standard of Care

NO INTERVENTION

The Standard of care as outlined in the Malawi HIV integrated Care Guidelines

Interventions

Community based peer supportOTHER

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
Facility-based Peer SupportOTHER

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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected women Presenting for Antenatal Care, Labor\&Delivery, or post-partum Infants of Enrolled mothers Husbands/Spouses of Enrolled mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Facilities

Lilongwe, Malawi

RECRUITING

Related Publications (6)

  • 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.

    PMID: 28693525DERIVED

  • 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.

    PMID: 28498193DERIVED

  • 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.

    PMID: 28498184DERIVED

  • 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.

    PMID: 28498183DERIVED

  • 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.

    PMID: 28045712DERIVED

  • 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.

    PMID: 27095249DERIVED

Study Officials

  • Sam Phiri, PhD, MSc.

    Lighthouse Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clement Trapence, MSc.

CONTACT

265 1 758897c_Trapence@lighthouse.org.mw

Hannock Tweya, M.P.H.

CONTACT

265 1 758897h_Tweya@lighthouse.org.mw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 9, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Study Completion

August 1, 2016

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

MA(1)