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Completed

NCT Number: NCT03058484

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

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.

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Key information

Conditions

Vertical Transmission of Infectious Disease Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Health Worker Intervention

Behavioral

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 outcomes

  1. Retention in HIV care

    Time frame: 120 days postpartum

    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 outcomes

  1. Adherence to ARVs

    Time frame: Birth to 90 days postpartum

    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.

  2. Timing of ART initiation

    Time frame: ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks

    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).

  3. Initiation of ART

    Time frame: Through pregnancy and up to 90 days after birth

    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).

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Amref Health Africa
  • International Initiative for Impact Evaluation
  • Ministry of Health and Social Welfare, Tanzania
  • Organization for Public Health Interventions and Development

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2017
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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