Clinical trial NCT01932138: Trial to Improve Access to PMTCT Services and Reduce HIV Transmission From Mother to Child
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mother-to-child Transmission of HIV
Pregnancy
Keywords: Community-based intervention
Community health workers
Antenatal care
HIV
PMTCT
HIV vertical transmission
Public-sector health systems
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Management and Development for Health, Tanzania
name: Elton John AIDS Foundation
name: Comic Relief UK
First posted: 2013-08-30
Enrollment: 190530
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Proportion of infants born to HIV-infected mothers who have acquired HIV
timeFrame: During the first 2 years of life
measure: Proportion of HIV-exposed infants tested for HIV
timeFrame: During the first 2 years of life
measure: Proportion of pregnant women making at least four antenatal clinic visits
timeFrame: Between the first week of gestation and delivery
measure: Proportion of pregnant women delivering at a healthcare facility
timeFrame: At delivery
measure: Proportion of HIV-positive women receiving PMTCT
timeFrame: Between the first antenatal care visit and 1 week after stopping breastfeeding
Secondary outcomes:
measure: Number of weeks of gestation at which pregnant women have their first ANC visit
timeFrame: Between the first week of gestation and delivery
measure: Proportion of HIV-infected pregnant women who completed PMTCT
timeFrame: Between the first antenatal care visit and 1 week after stopping breastfeeding
measure: Proportion of HIV-exposed infants who received PMTCT
timeFrame: During the first 2 years of life
measure: Proportion of pregnant women who were tested for HIV
timeFrame: Between the first week of gestation and delivery
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Management and Development for Health
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Till Bärnighausen, MD ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Management and Development for Health
name: Guerino Chalamilla, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Ekstrom AM, Fawzi WW, Barnighausen 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.
citation: Geldsetzer P, Mboggo E, Larson E, Lema IA, Magesa L, Machumi L, Ulenga N, Sando D, Mwanyika-Sando M, Spiegelman D, Mungure E, Li N, Siril H, Mujinja P, Naburi H, Chalamilla G, Kilewo C, Ekstrom AM, Foster D, Fawzi W, Barnighausen T. Community health workers to improve uptake of maternal healthcare services: A cluster-randomized pragmatic trial in Dar es Salaam, Tanzania. PLoS Med. 2019 Mar 29;16(3):e1002768. doi: 10.1371/journal.pmed.1002768. eCollection 2019 Mar.