Trial to Improve Access to PMTCT Services and Reduce HIV Transmission From Mother to Child (FS)
|ClinicalTrials.gov Identifier: NCT01932138|
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : March 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Mother-to-child Transmission of HIV Pregnancy||Other: Enhanced CHW intervention Other: Standard of care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190530 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: Enhanced CHW intervention
CHWs will 1) identify pregnant women through home visits and refer them to ANC; 2) inform pregnant women on antenatal care ANC and PMTCT; 3) visit women at home to ascertain ANC attendance; and 4) follow up women who have missed ANC or PMTCT appointments.
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
Clinic-based health workers follow-up patients who have missed scheduled PMTCT appointments (through telephone calls and/or in-person visits). The standard of care does not include any specific interventions to improve ANC attendance.
Other: 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).
- Proportion of infants born to HIV-infected mothers who have acquired HIV [ Time Frame: During the first 2 years of life ]
- Proportion of HIV-exposed infants tested for HIV [ Time Frame: During the first 2 years of life ]
- Proportion of pregnant women making at least four antenatal clinic visits [ Time Frame: Between the first week of gestation and delivery ]
- Proportion of pregnant women delivering at a healthcare facility [ Time Frame: At delivery ]
- Proportion of HIV-positive women receiving PMTCT [ Time Frame: Between the first antenatal care visit and 1 week after stopping breastfeeding ]
- Number of weeks of gestation at which pregnant women have their first ANC visit [ Time Frame: Between the first week of gestation and delivery ]
- Proportion of HIV-infected pregnant women who completed PMTCT [ Time Frame: Between the first antenatal care visit and 1 week after stopping breastfeeding ]
- Proportion of HIV-exposed infants who received PMTCT [ Time Frame: During the first 2 years of life ]
- Proportion of pregnant women who were tested for HIV [ Time Frame: Between the first week of gestation and delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932138
|Management and Development for Health|
|Dar es Salaam, Tanzania, 79810|
|Principal Investigator:||Till Bärnighausen, MD ScD||Harvard School of Public Health|
|Principal Investigator:||Guerino Chalamilla, MD PhD||Management and Development for Health|