Mother-to-child Transmission of HIVFSNCT01932138
Trial to Improve Access to PMTCT Services and Reduce HIV Transmission From Mother to Child
A study testing Enhanced CHW intervention in people with Mother-to-child Transmission of HIV and Pregnancy, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother-to-child Transmission of HIV, Pregnancy
- What is being tested?
- Enhanced CHW intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190,530 participants
- Where
- 1 siteTanzania
- Study dates
- Jan 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All pregnant women who are identified by the CHW during the routine household visits
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mother-to-child Transmission of HIV, Pregnancy
- Being tested
- Enhanced CHW intervention, Standard of care
- Keywords
- Community-based intervention, Community health workers, Antenatal care, HIV, PMTCT, HIV vertical transmission, Public-sector health systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CHW interventionOther
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 careOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced CHW intervention | Experimental | 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. Receives: Other: Enhanced CHW intervention |
| Standard of care | Other | 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants born to HIV-infected mothers who have acquired HIV
Measured: During the first 2 years of life
Proportion of HIV-exposed infants tested for HIV
Measured: During the first 2 years of life
Proportion of pregnant women making at least four antenatal clinic visits
Measured: Between the first week of gestation and delivery
Proportion of pregnant women delivering at a healthcare facility
Measured: At delivery
Proportion of HIV-positive women receiving PMTCT
Measured: Between the first antenatal care visit and 1 week after stopping breastfeeding
Secondary outcomes (4)
Number of weeks of gestation at which pregnant women have their first ANC visit
Measured: Between the first week of gestation and delivery
Proportion of HIV-infected pregnant women who completed PMTCT
Measured: Between the first antenatal care visit and 1 week after stopping breastfeeding
Proportion of HIV-exposed infants who received PMTCT
Measured: During the first 2 years of life
Proportion of pregnant women who were tested for HIV
Measured: Between the first week of gestation and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mother-to-child Transmission of HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Management and Development for Health, Tanzania, Elton John AIDS Foundation, Comic Relief UK
- Responsible party
- Principal investigator, Till Barnighausen, Harvard School of Public Health (HSPH)
- Investigators
- Till Bärnighausen, MD ScD, Principal investigator, Harvard School of Public Health (HSPH)Guerino Chalamilla, MD PhD, Principal investigator, Management and Development for Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932138
- Sponsor's protocol ID
- EJF22802
- Acronym
- FS
- Status last verified
- Feb 2015
- First submitted
- 14 May 2013
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25224756Geldsetzer 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.
PubMed 30925181
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01932138
- Acronym / sponsor ID
- FS / EJF22802
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190,530 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Management and Development for Health, Tanzania, Elton John AIDS Foundation, Comic Relief UK
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced CHW intervention | Experimental | Other: Enhanced CHW interventionCHWs 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. |
| Standard of care | Other | Other: Standard of careClinic-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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women who are identified by the CHW during the routine household visits
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced CHW interventionThe 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. | Other | Enhanced CHW intervention |
| Standard of careThe 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). | Other | Standard of care |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Background: PubMed 25224756Sando 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.
- Derived from this study: PubMed 30925181Geldsetzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Till Bärnighausen, MD ScD principal investigator
Harvard School of Public Health (HSPH)
Guerino Chalamilla, MD PhD principal investigator
Management and Development for Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced CHW intervention in people with Mother-to-child Transmission of HIV and Pregnancy, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of infants born to HIV-infected mothers who have acquired HIV (time frame: During the first 2 years of life). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932138, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.