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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058484
• Other study ID #: TW7.18
• Secondary ID: 552553838b402
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 20, 2017
• Start date: May 1, 2015
• Est. completion date: March 30, 2016

Study information

• Verified date: February 2017
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1830
• Est. completion date: March 30, 2016
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Vertical Transmission of Infectious Disease

Intervention

Behavioral:
• Community Health Worker intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Berkeley	Amref Health Africa, International Initiative for Impact Evaluation, Ministry of Health and Social Welfare, Tanzania, Organisation for Public Health Interventions and Development (OPHID)

References & Publications (5)

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. Review. — View Citation

Geldsetzer P, Yapa HM, Vaikath M, Ogbuoji O, Fox MP, Essajee SM, Negussie EK, Bärnighausen 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. Review. — View 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. — View 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):2080-9. doi: 10.1016/S0140-6736(09)61674-3. — View 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;16:18586. doi: 10.7448/IAS.16.1.18586. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	120 days postpartum
Secondary	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.	Birth to 90 days postpartum
Secondary	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).	ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks
Secondary	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).	Through pregnancy and up to 90 days after birth