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Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania

Primary Purpose

Vertical Transmission of Infectious Disease, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community Health Worker intervention
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vertical Transmission of Infectious Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015).

Exclusion Criteria:

  • Did not have sufficient information to link them across registers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Community Health Worker Intervention

    Arm Description

    Standard of care, i.e. regular clinic services are provided prior to the study.

    This arm is a four-part behavioral intervention that includes: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool.

    Outcomes

    Primary Outcome Measures

    Retention in HIV care
    Binary variable taking the value of 1 if the women has had at least one clinic visit in the postpartum period (60-120 days after birth), and zero otherwise.

    Secondary Outcome Measures

    Adherence to ARVs
    ART adherence will be measured through a binary variable taking the value of 1 when adherence is at least 95%, and the value of zero otherwise. We measure adherence using the medication possession ratio (MPR), computed as the number of days ARVs are prescribed or dispensed divided by the number of days in the interval. It has been shown to be associated with short-term virologic outcomes.
    Timing of ART initiation
    Defined by gestational week at start of ART, which was computed using standard approaches (i.e., 40 weeks prior to the date of birth or, when available, the expected delivery date based on last menstrual period).
    Initiation of ART
    Measured as the number of HIV-infected women in the sample who had any evidence of beginning ART after pregnancy, among women without evidence of treatment prior to pregnancy (women who had initiated ART before the current pregnancy were excluded).

    Full Information

    First Posted
    February 8, 2017
    Last Updated
    February 20, 2017
    Sponsor
    University of California, Berkeley
    Collaborators
    Amref Health Africa, Ministry of Health and Social Welfare, Tanzania, International Initiative for Impact Evaluation, Organisation for Public Health Interventions and Development (OPHID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03058484
    Brief Title
    Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania
    Official Title
    Short-term Effectiveness of a Community Health Worker Intervention for HIV-infected Pregnant Women in Tanzania to Improve Treatment Adherence and Retention in Care: A Cluster-Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    March 30, 2016 (Actual)
    Study Completion Date
    March 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Berkeley
    Collaborators
    Amref Health Africa, Ministry of Health and Social Welfare, Tanzania, International Initiative for Impact Evaluation, Organisation for Public Health Interventions and Development (OPHID)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). The intervention aimed to integrate community-based maternal and child health services with HIV prevention, treatment, and care-bridging the gap between women and facility, and enhancing the potential benefits of Option B+. Option B+ is the current World Health Organization recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals like CHWs can be key partners in the delivery and/or enhancement of health services in the community. The study focuses on whether this approach: increases retention in care; improves adherence to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy and the timing of initiation. Investigators hypothesize improvements along primary and secondary outcome indicators in the treatment group. This evaluation helps illuminate both the impact and feasibility of the intervention, and the role that CHWs may play in the elimination of mother-to-child transmission services.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vertical Transmission of Infectious Disease, HIV Infections

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1830 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Standard of care, i.e. regular clinic services are provided prior to the study.
    Arm Title
    Community Health Worker Intervention
    Arm Type
    Experimental
    Arm Description
    This arm is a four-part behavioral intervention that includes: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Community Health Worker intervention
    Intervention Description
    The intervention included four integrated components: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool.
    Primary Outcome Measure Information:
    Title
    Retention in HIV care
    Description
    Binary variable taking the value of 1 if the women has had at least one clinic visit in the postpartum period (60-120 days after birth), and zero otherwise.
    Time Frame
    120 days postpartum
    Secondary Outcome Measure Information:
    Title
    Adherence to ARVs
    Description
    ART adherence will be measured through a binary variable taking the value of 1 when adherence is at least 95%, and the value of zero otherwise. We measure adherence using the medication possession ratio (MPR), computed as the number of days ARVs are prescribed or dispensed divided by the number of days in the interval. It has been shown to be associated with short-term virologic outcomes.
    Time Frame
    Birth to 90 days postpartum
    Title
    Timing of ART initiation
    Description
    Defined by gestational week at start of ART, which was computed using standard approaches (i.e., 40 weeks prior to the date of birth or, when available, the expected delivery date based on last menstrual period).
    Time Frame
    ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks
    Title
    Initiation of ART
    Description
    Measured as the number of HIV-infected women in the sample who had any evidence of beginning ART after pregnancy, among women without evidence of treatment prior to pregnancy (women who had initiated ART before the current pregnancy were excluded).
    Time Frame
    Through pregnancy and up to 90 days after birth

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015). Exclusion Criteria: Did not have sufficient information to link them across registers

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23509605
    Citation
    Hong SY, Jerger L, Jonas A, Badi A, Cohen S, Nachega JB, Parienti JJ, Tang AM, Wanke C, Terrin N, Pereko D, Blom A, Trotter AB, Jordan MR. Medication possession ratio associated with short-term virologic response in individuals initiating antiretroviral therapy in Namibia. PLoS One. 2013;8(2):e56307. doi: 10.1371/journal.pone.0056307. Epub 2013 Feb 28.
    Results Reference
    background
    PubMed Identifier
    19939445
    Citation
    Jaffar S, Amuron B, Foster S, Birungi J, Levin J, Namara G, Nabiryo C, Ndembi N, Kyomuhangi R, Opio A, Bunnell R, Tappero JW, Mermin J, Coutinho A, Grosskurth H; Jinja trial team. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. Lancet. 2009 Dec 19;374(9707):2080-2089. doi: 10.1016/S0140-6736(09)61674-3. Epub 2009 Nov 24.
    Results Reference
    background
    PubMed Identifier
    27118443
    Citation
    Geldsetzer P, Yapa HM, Vaikath M, Ogbuoji O, Fox MP, Essajee SM, Negussie EK, Barnighausen T. A systematic review of interventions to improve postpartum retention of women in PMTCT and ART care. J Int AIDS Soc. 2016 Apr 25;19(1):20679. doi: 10.7448/IAS.19.1.20679. eCollection 2016.
    Results Reference
    background
    PubMed Identifier
    24029015
    Citation
    Mwai GW, Mburu G, Torpey K, Frost P, Ford N, Seeley J. Role and outcomes of community health workers in HIV care in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2013 Sep 10;16(1):18586. doi: 10.7448/IAS.16.1.18586.
    Results Reference
    background
    PubMed Identifier
    17617671
    Citation
    Anyangwe SC, Mtonga C. Inequities in the global health workforce: the greatest impediment to health in sub-Saharan Africa. Int J Environ Res Public Health. 2007 Jun;4(2):93-100. doi: 10.3390/ijerph2007040002.
    Results Reference
    background
    PubMed Identifier
    28859083
    Citation
    Nance N, Pendo P, Masanja J, Ngilangwa DP, Webb K, Noronha R, McCoy SI. Short-term effectiveness of a community health worker intervention for HIV-infected pregnant women in Tanzania to improve treatment adherence and retention in care: A cluster-randomized trial. PLoS One. 2017 Aug 31;12(8):e0181919. doi: 10.1371/journal.pone.0181919. eCollection 2017.
    Results Reference
    derived

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    Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania

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