Trial to Improve Access to PMTCT Services and Reduce HIV Transmission From Mother to Child

Pregnancy Clinical Trial

— FS  

Official title:

Evaluation of Interventions to Achieve Universal Access to PMTCT Services and Reduce Mother-to-Child Transmission of HIV in Dar es Salaam, Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932138
• Other study ID #: EJF22802
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: February 26, 2015
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2015
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: National Institute of Medical Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness, cost-effectiveness, feasibility and acceptability of an enhanced community health worker (CHW) intervention and outreach system to improve antenatal care and PMTCT uptake and retention, and to decrease mother-to-child HIV transmission.

Description:

Mother-to-child transmission of HIV/AIDS (MTCT) is still a major contributor to the burden of HIV infections among infants and children in Sub-Saharan Africa. Among the major challenges of each approach to achieving maximum benefits is late and incomplete antenatal care (ANC) attendance. While attendance to one ANC visit is almost universal, only about half of pregnant women attend the four WHO-recommended visits. Moreover, those that attend often book late in pregnancy. This nationwide challenge can lead to delays or interferences with the appropriate PMTCT medications for mothers —thus substantially diminishing the potential of PMTCT care to reduce mother-to child-transmission of HIV in Tanzania.

The investigators will examine the effectiveness, cost-effectiveness, feasibility, and acceptability of an enhanced community health worker intervention and outreach system for pregnant women to facilitate early and consistent ANC attendance, early and effective PMTCT uptake, with the aim to further reduce mother-to-child transmission of HIV. We will test the effectiveness hypothesis in a cluster-randomized controlled trial; the unit of randomization is the administrative unit of a ward, which is the geographical unit below a district in the Tanzanian government system. We randomly allocate all 60 wards in two of the three districts in Dar es Salaam, Tanzania -- Kinondoni and Ilala districts -- to receiving the enhanced community health worker intervention and outreach system vs. receiving the standard of care in the Tanzanian public-sector health system.

The results of this study will inform implementers and policy makers on whether and how a community outreach system and PMTCT algorithm may maximize benefits of antenatal care and PMTCT services in Tanzania and inform decisions surrounding future maternal and newborn health programs moving forward.

This study was initially designed to test both the effectiveness of the enhanced CHW intervention and outreach system and the effectiveness of WHO PMTCT option B (vs. A) in ensuring successful PMTCT in the Tanzanian public-sector health system. However, in reaction to a report of non-compliance by the investigator team (incomplete records of written informed consent among PMTCT patients in the public-sector PMTCT clinics) the IRB at the Harvard School of Public Health decided to stop involvement in the option A vs. B component of this study. The IRB approved continuation of the enhanced CHW intervention and outreach system in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190530
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All pregnant women who are identified by the CHW during the routine household visits

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mother-to-child Transmission of HIV
• Pregnancy

Intervention

Other:
• Enhanced CHW intervention
The CHW employed in this study are a health worker cadre that already exists in the Tanzanian public-sector health system, so-called "home-base carers" (or HBC). The HBC in this study are supervised by another existing cadre, so-called "community-based health care workers" (or CBHC). The CBHC are clinic-based and are charged to organize community outreach activities in the Tanzanian public-sector health systems. The CBHC (1-2 per clinic) are also active in the control arm; in this intervention arm, there role is changed: they are actively supervising a large number of CHW. Per street (or mtaa), 1-2 CHW are assigned to carry out the enhanced CHW intervention.
• Standard of care
The standard of care in the Tanzanian health care system does not include any CHW intervention to enhance ANC and PMTCT uptake and retention. The only community-based intervention are PMTCT follow-up organized by a health worker cadre who works out of ANC and primary care clinics (so-called CBHC).

Locations

Country	Name	City	State
Tanzania	Management and Development for Health	Dar es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health	Comic Relief UK, Elton John AIDS Foundation, UK, Management and Development for Health, Tanzania

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

Sando D, Geldsetzer P, Magesa L, Lema IA, Machumi L, Mwanyika-Sando M, Li N, Spiegelman D, Mungure E, Siril H, Mujinja P, Naburi H, Chalamilla G, Kilewo C, Ekström AM, Fawzi WW, Bärnighausen TW. Evaluation of a community health worker intervention and the World Health Organization's Option B versus Option A to improve antenatal care and PMTCT outcomes in Dar es Salaam, Tanzania: study protocol for a cluster-randomized controlled health systems implementation trial. Trials. 2014 Sep 15;15:359. doi: 10.1186/1745-6215-15-359. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of infants born to HIV-infected mothers who have acquired HIV		During the first 2 years of life	No
Primary	Proportion of HIV-exposed infants tested for HIV		During the first 2 years of life	No
Primary	Proportion of pregnant women making at least four antenatal clinic visits		Between the first week of gestation and delivery	No
Primary	Proportion of pregnant women delivering at a healthcare facility		At delivery	No
Primary	Proportion of HIV-positive women receiving PMTCT		Between the first antenatal care visit and 1 week after stopping breastfeeding	No
Secondary	Number of weeks of gestation at which pregnant women have their first ANC visit		Between the first week of gestation and delivery	No
Secondary	Proportion of HIV-infected pregnant women who completed PMTCT		Between the first antenatal care visit and 1 week after stopping breastfeeding	No
Secondary	Proportion of HIV-exposed infants who received PMTCT		During the first 2 years of life	No
Secondary	Proportion of pregnant women who were tested for HIV		Between the first week of gestation and delivery	No