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

About this trial
This is an interventional prevention trial for Vertical Transmission of Infectious Disease
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
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
NCT ID
NCT03058484
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)
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
Learn more about this trial
Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania
We'll reach out to this number within 24 hrs