HIV/AIDSFCCNCT03880175
Direct and Spillover Impacts of a Community-Level HIV/AIDS Program
A study testing FCC (Força à Comunidade e Crianças) program- direct beneficiary, FCC (Força à Comunidade e Crianças) program- non-direct beneficiary and Anti Stigma Information in people with HIV/AIDS, run by University of Michigan at 1 site in Mozambique.
Trial summary
The HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- FCC (Força à Comunidade e Crianças) program- direct beneficiary, FCC (Força à Comunidade e Crianças) program- non-direct beneficiary and Anti Stigma Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,658 participants
- Where
- 1 siteMozambique
- Study dates
- 1 Jan 2017to 30 Jun 2021
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Households that lives in one of the eligible communities.
Who cannot join
- Households that are not in the eligible communities will not be included in the survey sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique
The HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being.
A variety of health and economic interventions to help orphans and vulnerable children (OVCs) (and the households in which they live) are being carried out in Mozambique by World Education Inc./Bantwana (WEI/B), funded by USAID. The program is known in Portuguese as Força à Comunidade e Crianças or FCC (in English, "Strengthening Family and Communities").
Read more
This study will collect survey and administrative data to assess the impact of the FCC program on OVCs and the households in which they live. A baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics.
Follow-up data collection will begin in March 2019. It has several components:
- Household survey The follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the FCC program.
- Data collection on HIV testing and school attendance This study will supplement survey-reported HIV testing rates with an objective, administrative measure of HIV testing at health clinics. At the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for HIV at a specified local health clinic. To allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an HIV test. In addition to self-reported data on school participation by children, this study will also measure school participation directly. Both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. Project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community.
- Informational treatments aimed at raising HIV testing rates To allow insight into the mechanisms through which the FCC program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible FCC mechanisms: stigma reduction, HIV/AIDS information, and HIV treatment (antiretroviral therapy, or ART) information.
- Conditions
- HIV/AIDS
- Being tested
- FCC (Força à Comunidade e Crianças) program- direct beneficiary, FCC (Força à Comunidade e Crianças) program- non-direct beneficiary, Anti Stigma Information, HIV/AIDS Information, ART Information
- 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.
FCC (Força à Comunidade e Crianças) program- direct beneficiaryBehavioural
Households are directly linked to the FCC implementing organization
FCC (Força à Comunidade e Crianças) program- non-direct beneficiaryBehavioural
Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
Anti Stigma InformationBehavioural
Adults in the households are provided anti-stigma information
HIV/AIDS InformationBehavioural
The households receive information about HIV infection and AIDS
ART InformationBehavioural
The households receive information about antiretroviral therapy.
HIV/AIDS and ART Information CombinedBehavioural
The households receive both information about HIV/AIDS and information about antiretroviral therapy.
High coupon valueBehavioural
The HIV testing coupons distributed to households in this group have higher values.
| Study group | Role | What they receive |
|---|---|---|
| FCC DEB and Anti-stigma | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Behavioral: Anti Stigma Information |
| FCC DEB and HIV info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Behavioral: HIV/AIDS Information |
| FCC DEB and ART info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Behavioral: ART Information |
| FCC DEB and HIV-ART info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Behavioral: HIV/AIDS and ART Information Combined |
| FCC DEB and high coupon value | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary; Behavioral: High coupon value |
| FCC DEB and no info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary |
| FCC non-DEB and Anti-stigma | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Behavioral: Anti Stigma Information |
| FCC non-DEB and HIV info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Behavioral: HIV/AIDS Information |
| FCC non-DEB and ART info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Behavioral: ART Information |
| FCC non-DEB and HIV-ART info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Behavioral: HIV/AIDS and ART Information Combined |
| FCC non-DEB and high coupon value | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary; Behavioral: High coupon value |
| FCC non-DEB and no info | Experimental | Not described Receives: Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary |
| FCC control and Anti-stigma | Experimental | Not described Receives: Behavioral: Anti Stigma Information |
| FCC control and HIV info | Experimental | Not described Receives: Behavioral: HIV/AIDS Information |
| FCC control and ART info | Experimental | Not described Receives: Behavioral: ART Information |
| FCC control and HIV-ART info | Experimental | Not described Receives: Behavioral: HIV/AIDS and ART Information Combined |
| FCC control and High coupon value | Experimental | Not described Receives: Behavioral: High coupon value |
| FCC control and no info | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indicator for HIV testing coupon redemption at the household level
This is a household-level binary variable. It takes value 1 if at least one of a household's coupons is redeemed, and 0 otherwise.
The researcher will distribute coupons at the household survey. A subject is eligible for a coupon if s/he is not reported HIV+ and has not had an HIV test within 3 months before the visit. A coupon for an adult will be distributed to themselves. A coupon for a child (age <18) will be distributed to their primary guardian. Each coupon has a value of 50Mts (0.83 USD) and is valid for 14 days.
To redeem a coupon, a coupon holder must show up in the designated clinic and provide proof of testing dated within the coupon-validity window.
There is a unique barcode on each coupon to allow the researcher to track the use of each coupon. A coupon will be scanned when distributed and redeemed to link to a subject.
The analysis sample for this outcome of interest is all households that have received at least one coupon from the researcher.
Measured: 14 days following the date coupons are distributed to a household.
Indicator for school attendance at the child-level
This is an individual-level binary variable. It takes value 1 if a school-aged child (6 -17 years of age) is physically present at school on the date the research staff conducts an unannounced school visit; it takes the value of 0 otherwise.
The research team will make an unannounced school visit to check the attendance of all school-aged children in the study sample. All school-aged children will be checked regardless of his or her guardian-reported school attendance status. The study team will visit all public primary and secondary schools located in the study community. All unannounced visits will happen on regular school days. Each child will be checked in all neighboring schools. Each child will only be checked once in one school.
The analysis sample of this outcome of interest is all school-aged children living in the study households.
Measured: The time when the research team is conducting the school visit, which lasts 4 to 8 hours in each school
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Jan 2017
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,658 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dean Yang, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880175
- Sponsor's protocol ID
- HUM00113011
- Other IDs
- AID-OAA-L-12-00001, AID-OAA-LA-16-0004, AID391A1500006
- Acronym
- FCC
- Status last verified
- Aug 2021
- First submitted
- 15 Mar 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique
- ClinicalTrials.gov ID
- NCT03880175
- Acronym / sponsor ID
- FCC / HUM00113011
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,658 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- 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 HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being.
A variety of health and economic interventions to help orphans and vulnerable children (OVCs) (and the households in which they live) are being carried out in Mozambique by World Education Inc./Bantwana (WEI/B), funded by USAID. The program is known in Portuguese as Força à Comunidade e Crianças or FCC (in English, "Strengthening Family and Communities").
This study will collect survey and administrative data to assess the impact of the FCC program on OVCs and the households in which they live. A baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics.
Follow-up data collection will begin in March 2019. It has several components:
- Household survey The follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the FCC program.
- Data collection on HIV testing and school attendance This study will supplement survey-reported HIV testing rates with an objective, administrative measure of HIV testing at health clinics. At the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for HIV at a specified local health clinic. To allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an HIV test. In addition to self-reported data on school participation by children, this study will also measure school participation directly. Both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. Project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community.
- Informational treatments aimed at raising HIV testing rates To allow insight into the mechanisms through which the FCC program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible FCC mechanisms: stigma reduction, HIV/AIDS information, and HIV treatment (antiretroviral therapy, or ART) information.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| FCC DEB and Anti-stigma | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary, Behavioral: Anti Stigma Information |
| FCC DEB and HIV info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary, Behavioral: HIV/AIDS Information |
| FCC DEB and ART info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary, Behavioral: ART Information |
| FCC DEB and HIV-ART info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary, Behavioral: HIV/AIDS and ART Information Combined |
| FCC DEB and high coupon value | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary, Behavioral: High coupon value |
| FCC DEB and no info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- direct beneficiary |
| FCC non-DEB and Anti-stigma | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary, Behavioral: Anti Stigma Information |
| FCC non-DEB and HIV info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary, Behavioral: HIV/AIDS Information |
| FCC non-DEB and ART info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary, Behavioral: ART Information |
| FCC non-DEB and HIV-ART info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary, Behavioral: HIV/AIDS and ART Information Combined |
| FCC non-DEB and high coupon value | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary, Behavioral: High coupon value |
| FCC non-DEB and no info | Experimental | Behavioral: FCC (Força à Comunidade e Crianças) program- non-direct beneficiary |
| FCC control and Anti-stigma | Experimental | Behavioral: Anti Stigma Information |
| FCC control and HIV info | Experimental | Behavioral: HIV/AIDS Information |
| FCC control and ART info | Experimental | Behavioral: ART Information |
| FCC control and HIV-ART info | Experimental | Behavioral: HIV/AIDS and ART Information Combined |
| FCC control and High coupon value | Experimental | Behavioral: High coupon value |
| FCC control and no info | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Households that lives in one of the eligible communities.
Key exclusion criteria (1 listed)
- Households that are not in the eligible communities will not be included in the survey sample.
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 |
|---|---|---|
| FCC (Força à Comunidade e Crianças) program- direct beneficiaryHouseholds are directly linked to the FCC implementing organization | Behavioural | FCC DEB and ART info, FCC DEB and Anti-stigma, FCC DEB and HIV info, FCC DEB and HIV-ART info, FCC DEB and high coupon value, FCC DEB and no info |
| FCC (Força à Comunidade e Crianças) program- non-direct beneficiaryHouseholds live in FCC implementing communities but are not directly linked to the FCC implementing organization | Behavioural | FCC non-DEB and ART info, FCC non-DEB and Anti-stigma, FCC non-DEB and HIV info, FCC non-DEB and HIV-ART info, FCC non-DEB and high coupon value, FCC non-DEB and no info |
| Anti Stigma InformationAdults in the households are provided anti-stigma information | Behavioural | FCC DEB and Anti-stigma, FCC control and Anti-stigma, FCC non-DEB and Anti-stigma |
| HIV/AIDS InformationThe households receive information about HIV infection and AIDS | Behavioural | FCC DEB and HIV info, FCC control and HIV info, FCC non-DEB and HIV info |
| ART InformationThe households receive information about antiretroviral therapy. | Behavioural | FCC DEB and ART info, FCC control and ART info, FCC non-DEB and ART info |
| HIV/AIDS and ART Information CombinedThe households receive both information about HIV/AIDS and information about antiretroviral therapy. | Behavioural | FCC DEB and HIV-ART info, FCC control and HIV-ART info, FCC non-DEB and HIV-ART info |
| High coupon valueThe HIV testing coupons distributed to households in this group have higher values. | Behavioural | FCC DEB and high coupon value, FCC control and High coupon value, FCC non-DEB and high coupon value |
Primary outcome
Indicator for HIV testing coupon redemption at the household level
Time frame: 14 days following the date coupons are distributed to a household.
This is a household-level binary variable. It takes value 1 if at least one of a household's coupons is redeemed, and 0 otherwise. The researcher will distribute coupons at the household survey. A subject is eligible for a coupon if s/he is not reported HIV+ and has not had an HIV test within 3 months before the visit. A coupon for an adult will be distributed to themselves. A coupon for a child (age <18) will be distributed to their primary guardian. Each coupon has a value of 50Mts (0.83 USD) and is valid for 14 days. To redeem a coupon, a coupon holder must show up in the designated clinic and provide proof of testing dated within the coupon-validity window. There is a unique barcode on each coupon to allow the researcher to track the use of each coupon. A coupon will be scanned when distributed and redeemed to link to a subject. The analysis sample for this outcome of interest is all households that have received at least one coupon from the researcher.
Indicator for school attendance at the child-level
Time frame: The time when the research team is conducting the school visit, which lasts 4 to 8 hours in each school
This is an individual-level binary variable. It takes value 1 if a school-aged child (6 -17 years of age) is physically present at school on the date the research staff conducts an unannounced school visit; it takes the value of 0 otherwise. The research team will make an unannounced school visit to check the attendance of all school-aged children in the study sample. All school-aged children will be checked regardless of his or her guardian-reported school attendance status. The study team will visit all public primary and secondary schools located in the study community. All unannounced visits will happen on regular school days. Each child will be checked in all neighboring schools. Each child will only be checked once in one school. The analysis sample of this outcome of interest is all school-aged children living in the study households.
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 12 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCC (Força à Comunidade e Crianças) program- direct beneficiary, FCC (Força à Comunidade e Crianças) program- non-direct beneficiary and Anti Stigma Information in people with HIV/AIDS, run by University of Michigan at 1 site in Mozambique.
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 12 Aug 2021. 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 Mozambique. 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?
Indicator for HIV testing coupon redemption at the household level (time frame: 14 days following the date coupons are distributed to a household.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2021.