HIVACCLAIMNCT01971710
Advancing Community Level Action for Improving MCH/PMTCT
A study testing Community leader engagement, Community days and Community Peer Groups in people with HIV, run by Elizabeth Glaser Pediatric AIDS Foundation at 3 sites in 3 countries.
Trial summary
The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country progress toward elimination of pediatric… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Community leader engagement, Community days and Community Peer Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187,335 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2013to Apr 2016
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a member of the community surveyed
Who cannot join
- Under 18 years of age
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Advancing Community Level Action for Improving MCH/PMTCT (ACCLAIM): A Multi-Country Randomized Trial to Evaluate the Effectiveness of Selected Community-Level Interventions on Key MCH/PMTCT Outcomes
The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country progress toward elimination of pediatric HIV/AIDS.
Read the detailed description
This study will undertake a three-arm randomized trial in Swaziland, Uganda and Zimbabwe. Districts/regions (n=9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7300-27500), will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEI) returning to the health facility within two months for early infant diagnosis (EID) of HIV. Secondary study outcomes include: gestational age of women attending for first antenatal care, male partners tested for HIV, and HEI receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices and beliefs on MCH/PMTCT will be assessed through household surveys.
- Conditions
- HIV
- Being tested
- Community leader engagement, Community days, Community Peer Groups
- Keywords
- HIV, AIDS, PMTCT
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community leader engagementBehavioural
Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
Community daysBehavioural
The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day
Community Peer GroupsBehavioural
Pregnant women in community peer groups receiving information and education on PMTCT/MCH through 4 weekly peer-led classes . Men in community peer groups receiving information and education on their role in supporting women and families through 4 peer-led education sessions.
| Study group | Role | What they receive |
|---|---|---|
| Community Leader Engagement | Other | Trained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans Receives: Behavioral: Community leader engagement |
| Community Days | Other | Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services. Receives: Behavioral: Community leader engagement; Behavioral: Community days |
| Community Peer Groups | Other | Pregnant women attend 4 weekly peer-led classes in community peer groups. Men attending 4 peer-led education sessions in community peer groups Receives: Behavioral: Community leader engagement; Behavioral: Community days; Behavioral: Community Peer Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HIV-exposed infants returning to health facility HIV testing
The general objective for the study is to assess the efficacy of the three study arm activities on the uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services as measured by the proportion of infants returning to the health facility at 6-8 weeks of age for the early infant diagnosis (EID) of HIV.
Measured: 6-8 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 187,335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian International Development Agency
- Responsible party
- Sponsor
- Investigators
- Godfrey Woelk, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971710
- Sponsor's protocol ID
- EG112/113/115
- Acronym
- ACCLAIM
- Status last verified
- Feb 2021
- First submitted
- 13 Aug 2013
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The dataset may be available in 2018. Enquiries may be made with the organization.
Publications
Woelk GB, Kieffer MP, Walker D, Mpofu D, Machekano R; Project ACCLAIM Study Group. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial. Trials. 2016 Feb 16;17:88. doi: 10.1186/s13063-016-1202-y.
PubMed 26883307
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Community Level Action for Improving MCH/PMTCT (ACCLAIM): A Multi-Country Randomized Trial to Evaluate the Effectiveness of Selected Community-Level Interventions on Key MCH/PMTCT Outcomes
- ClinicalTrials.gov ID
- NCT01971710
- Acronym / sponsor ID
- ACCLAIM / EG112/113/115
- Conditions
- HIV
- Keywords
- HIV, AIDS, PMTCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187,335 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Canadian International Development Agency
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Oct 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 goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country progress toward elimination of pediatric HIV/AIDS.
Detailed description
This study will undertake a three-arm randomized trial in Swaziland, Uganda and Zimbabwe. Districts/regions (n=9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7300-27500), will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEI) returning to the health facility within two months for early infant diagnosis (EID) of HIV. Secondary study outcomes include: gestational age of women attending for first antenatal care, male partners tested for HIV, and HEI receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices and beliefs on MCH/PMTCT will be assessed through household surveys.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community Leader Engagement | Other | Behavioral: Community leader engagementTrained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans |
| Community Days | Other | Behavioral: Community leader engagement, Behavioral: Community daysCommunity gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services. |
| Community Peer Groups | Other | Behavioral: Community leader engagement, Behavioral: Community days, Behavioral: Community Peer GroupsPregnant women attend 4 weekly peer-led classes in community peer groups. Men attending 4 peer-led education sessions in community peer groups |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a member of the community surveyed
Key exclusion criteria (1 listed)
- Under 18 years of age
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 |
|---|---|---|
| Community leader engagementCommunity leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH | Behavioural | Community Days, Community Leader Engagement, Community Peer Groups |
| Community daysThe provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day | Behavioural | Community Days, Community Peer Groups |
| Community Peer GroupsPregnant women in community peer groups receiving information and education on PMTCT/MCH through 4 weekly peer-led classes . Men in community peer groups receiving information and education on their role in supporting women and families through 4 peer-led education sessions. | Behavioural | Community Peer Groups |
Primary outcome
Proportion of HIV-exposed infants returning to health facility HIV testing
Time frame: 6-8 weeks after birth
The general objective for the study is to assess the efficacy of the three study arm activities on the uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services as measured by the proportion of infants returning to the health facility at 6-8 weeks of age for the early infant diagnosis (EID) of HIV.
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 8 Feb 2021.
- Derived from this study: PubMed 26883307Woelk GB, Kieffer MP, Walker D, Mpofu D, Machekano R; Project ACCLAIM Study Group. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial. Trials. 2016 Feb 16;17:88. doi: 10.1186/s13063-016-1202-y.
- Individual participant dataSharing planned: No. The dataset may be available in 2018. Enquiries may be made with the organization.
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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.
Godfrey Woelk, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community leader engagement, Community days and Community Peer Groups in people with HIV, run by Elizabeth Glaser Pediatric AIDS Foundation at 3 sites in 3 countries.
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 1 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Eswatini, Uganda, Zimbabwe. 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 HIV-exposed infants returning to health facility HIV testing (time frame: 6-8 weeks after birth). 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 NCT01971710, which also lists 1 linked publication.
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 8 Feb 2021.