HIV/AIDSCARENCT03597243
Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior - an Impact Evaluation
A study testing Cash Transfer in people with HIV/AIDS and HSV-2 Infection, run by National Institute for Medical Research, Tanzania at 1 site in Tanzania.
Trial summary
Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behavior. The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected… Read more about this study
- Who is it for?
- Ages 15 to 23 years, women only
- Conditions the study is for
- HIV/AIDS, HSV-2 Infection
- What is being tested?
- Cash Transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,120 participants
- Where
- 1 siteTanzania
- Study dates
- 30 Oct 2017to 15 Dec 2019
- 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 15 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent girls and young women aged 15-23 years.
- Graduated from ten hours of Sauti's BCC sessions.
- Resident of the village of recruitment
- Registered into Cash Transfer Program (CTP) (applicable in the CTP areas only).
- Currently out of school (currently not enrolled in primary, secondary or tertiary education. Either they have never been to school or have dropped out of school for at least a month at time of study enrolment) as documented through a previous household survey of the CT Program (Girls roster).
- Willing and able to give voluntary, informed consent/assent to all study procedures including HIV and HSV-2 testing and receive test results.
- (If <18 years) guardian of the minor AGYW is willing to consent for the study procedures except for emancipated minors (i.e. minors who are married, have given birth or demonstrating full independence e.g. living alone or heading the household).
Who cannot join
- Not willing or able to consent or assent to the study, in case of minor, no consent from guardian. All minors will require guardian consent except for emancipated minors.
- AGYW not willing to test for HIV or HSV-2 or to receive test results.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site, 1 recruiting
- Recruiting
Shinyanga region
Kahama
Albert Komba, MD, +255 22 2771346, albert.komba@jhpiego.org
Gasper Mbita, +255 767 898 956, Gaspar.Mbita@jhpiego.org
About this study
Official title: Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behaviour - an Impact Evaluation
Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behavior. The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected districts of Tanzania. The CARE study will evaluate the impact of this activity through a cluster randomised controlled trial that involves quantitative and qualitative research techniques. The study will inform policy makers on the impact of Cash transfer programs in AGYW as a tool to reduce vulnerability to HIV infection in Adolescent Girls and Young women.
Read the detailed description
Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behaviour. Poverty and few alternative opportunities to generate income make AGYW prone to compensated and often inter-generational and unprotected sex.
The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected districts of Tanzania. The CARE study will evaluate the impact of this activity through a cluster randomised controlled trial that involves quantitative and qualitative research techniques.
Cash transfer interacts with structural factors influencing sexual risk behavior in AGYW, providing alternative source to solve their social and economic needs and hence reducing the pressure to engage in compensated and unprotected sex which further reduces the risk of HSV-2 and HIV acquisition at the population level.
The proposed study (CARE study) is two parallel arms cluster-randomized controlled trial implemented in 3120 adolescent girls and young women (AGYW) aged 15-23 years followed up for 18 months. Participants in randomized clusters will receive a quarterly cash transfer payment through mobile money on their cellular phones in Arm I (Unconditional Cash Transfer) while Arm II will not receive cash transfer payments (Control). The study will be conducted in Kahama Town Council, Ushetu and Msalala District Councils in Shinyanga region in mainland Tanzania.
CARE study will enrol AGYW aged 15-23 years in 3 districts of Tanzania namely Msalala district, Ushetu district and Kahama town council in Shinyanga region. Villages in these areas will be eligible in the trial if they are:
- Sauti intervention villages receiving cash transfer or control villages ii) with at least 70 AGYW according to the household survey
AGYW found to be HIV and HSV-2 positive at baseline will not be excluded from the study because: 1) excluding them is likely to disclose their HIV or HSV-2 serostatus to the community and therefore expose them to stigma and other social harm; 2) Recruiting them is likely to increase their linkage to care and treatment and also likely to increase ART adherence; 3) They will participate in the interview and information collected will contribute to the study behavioural outcomes (reporting of compensated sex and inter-generational sex)
Up to 3120 participants (1560 participants per arm) will be screened and up to 3060 enrolled. This sample size will achieve 80% power to detect a 35% reduction of HSV-2 incidence between intervention and the control arms and this sample size is also enough to detect a difference in HIV prevalence between the groups of 35% between the intervention and control arms.
Control: No cash transfer.
Intervention: unconditional cash transfer (UCT) in quarterly instalments of 70,000 TSH. The first instalment will take place after completion of 10 hours of BCC sessions and the AGYW has registered into CTP.
- Conditions
- HIV/AIDS, HSV-2 Infection
- Being tested
- Cash Transfer
- Keywords
- Cash transfer, HIV, adolescent girls, Tanzania
- 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.
Cash TransferOther
Girls enrolled receive a quarterly direct cash transfer of a total of 70,000 Tshs (30 USD) quarterly through mobile phone based cash transfer over a period of two years, for which they will receive mobile phones and SIM cards form the program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | AGYW in the standard Sauti cash transfer (Arm I) will receive unconditional cash transfer (UCT) in the presence of behavioral and biomedical interventions in quarterly installments of 70,000 TSH. The first installment will take place after completion of 10 hours of BCC sessions and the AGYW has registered into CTP. Receives: Other: Cash Transfer |
| Control | No intervention | AGYW in the control group (Arm II) will not receive cash payment but will receive behavioral and biomedical interventions. The behavioral and biomedical interventions are provided by Sauti program to all project beneficiaries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSV-2 Incidence
Proportion of HSV-2 negative girls who are still free of HSV-2 across the two arms
Measured: 18 months of follow-up
Secondary outcomes (3)
HIV prevalence
HIV prevalence will be assessed by comparing the intervention arm against the control
Measured: 18 months of follow-up
reporting of compensated sex
Proportion of girls reporting compensated sex across the two arms
Measured: 18 months of follow-up
reporting of intergenerational sexual partnerships
Proportion of girls reporting intergenerational sexual partnerships across the two arms
Measured: 18 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start30 Oct 2017
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms parallel cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Research, Tanzania
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mwita Wambura, National Institute for Medical Research, Tanzania
- Investigators
- Mwita Wambura, PhD, Principal investigator, NIMR Mwanza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597243
- Sponsor's protocol ID
- 16.01.CT
- Acronym
- CARE
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the open data policy, all data emanating from this study will be shared with other researchers
Publications
Kuringe E, Christensen A, Materu J, Drake M, Majani E, Casalini C, Mjungu D, Mbita G, Kalage E, Komba A, Nyato D, Nnko S, Shao A, Changalucha J, Wambura M. Effectiveness of Cash Transfer Delivered Along With Combination HIV Prevention Interventions in Reducing the Risky Sexual Behavior of Adolescent Girls and Young Women in Tanzania: Cluster Randomized Controlled Trial. JMIR Public Health Surveill. 2022 Sep 19;8(9):e30372. doi: 10.2196/30372.
PubMed 36121686Wambura M, Drake M, Kuringe E, Majani E, Nyato D, Casalini C, Materu J, Mjungu D, Nnko S, Mbita G, Kalage E, Shao A, Changalucha J, Komba A. Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e14696. doi: 10.2196/14696.
PubMed 31859686Nyato D, Materu J, Kuringe E, Zoungrana J, Mjungu D, Lemwayi R, Majani E, Mtenga B, Nnko S, Munisi G, Shao A, Wambura M, Changalucha J, Drake M, Komba A. Prevalence and correlates of partner violence among adolescent girls and young women: Evidence from baseline data of a cluster randomised trial in Tanzania. PLoS One. 2019 Oct 8;14(10):e0222950. doi: 10.1371/journal.pone.0222950. eCollection 2019.
PubMed 31593577
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behaviour - an Impact Evaluation
- ClinicalTrials.gov ID
- NCT03597243
- Acronym / sponsor ID
- CARE / 16.01.CT
- Conditions
- HIV/AIDS, HSV-2 Infection
- Keywords
- Cash transfer, HIV, adolescent girls, Tanzania
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,120 participants (estimated)
- Lead sponsor
- National Institute for Medical Research, TanzaniaOther government
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 24 Jul 2018 (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.
Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behavior. The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected districts of Tanzania. The CARE study will evaluate the impact of this activity through a cluster randomised controlled trial that involves quantitative and qualitative research techniques. The study will inform policy makers on the impact of Cash transfer programs in AGYW as a tool to reduce vulnerability to HIV infection in Adolescent Girls and Young women.
Detailed description
Vulnerability to HIV infection in Adolescent Girls and Young Women (AGYW) is mainly influenced by structural factors which mediate through sexual risk behaviour. Poverty and few alternative opportunities to generate income make AGYW prone to compensated and often inter-generational and unprotected sex.
The Sauti program as implementing partner of the DREAMS initiative will provide unconditional cash transfer on quarterly basis to vulnerable AGYW in selected districts of Tanzania. The CARE study will evaluate the impact of this activity through a cluster randomised controlled trial that involves quantitative and qualitative research techniques.
Cash transfer interacts with structural factors influencing sexual risk behavior in AGYW, providing alternative source to solve their social and economic needs and hence reducing the pressure to engage in compensated and unprotected sex which further reduces the risk of HSV-2 and HIV acquisition at the population level.
The proposed study (CARE study) is two parallel arms cluster-randomized controlled trial implemented in 3120 adolescent girls and young women (AGYW) aged 15-23 years followed up for 18 months. Participants in randomized clusters will receive a quarterly cash transfer payment through mobile money on their cellular phones in Arm I (Unconditional Cash Transfer) while Arm II will not receive cash transfer payments (Control). The study will be conducted in Kahama Town Council, Ushetu and Msalala District Councils in Shinyanga region in mainland Tanzania.
CARE study will enrol AGYW aged 15-23 years in 3 districts of Tanzania namely Msalala district, Ushetu district and Kahama town council in Shinyanga region. Villages in these areas will be eligible in the trial if they are:
- Sauti intervention villages receiving cash transfer or control villages ii) with at least 70 AGYW according to the household survey
AGYW found to be HIV and HSV-2 positive at baseline will not be excluded from the study because: 1) excluding them is likely to disclose their HIV or HSV-2 serostatus to the community and therefore expose them to stigma and other social harm; 2) Recruiting them is likely to increase their linkage to care and treatment and also likely to increase ART adherence; 3) They will participate in the interview and information collected will contribute to the study behavioural outcomes (reporting of compensated sex and inter-generational sex)
Up to 3120 participants (1560 participants per arm) will be screened and up to 3060 enrolled. This sample size will achieve 80% power to detect a 35% reduction of HSV-2 incidence between intervention and the control arms and this sample size is also enough to detect a difference in HIV prevalence between the groups of 35% between the intervention and control arms.
Control: No cash transfer.
Intervention: unconditional cash transfer (UCT) in quarterly instalments of 70,000 TSH. The first instalment will take place after completion of 10 hours of BCC sessions and the AGYW has registered into CTP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms parallel cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cash TransferAGYW in the standard Sauti cash transfer (Arm I) will receive unconditional cash transfer (UCT) in the presence of behavioral and biomedical interventions in quarterly installments of 70,000 TSH. The first installment will take place after completion of 10 hours of BCC sessions and the AGYW has registered into CTP. |
| Control | No intervention | –AGYW in the control group (Arm II) will not receive cash payment but will receive behavioral and biomedical interventions. The behavioral and biomedical interventions are provided by Sauti program to all project beneficiaries. |
Who may qualify
- Ages
- 15 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adolescent girls and young women aged 15-23 years.
- Graduated from ten hours of Sauti's BCC sessions.
- Resident of the village of recruitment
- Registered into Cash Transfer Program (CTP) (applicable in the CTP areas only).
- Currently out of school (currently not enrolled in primary, secondary or tertiary education. Either they have never been to school or have dropped out of school for at least a month at time of study enrolment) as documented through a previous household survey of the CT Program (Girls roster).
Key exclusion criteria (2 listed)
- Not willing or able to consent or assent to the study, in case of minor, no consent from guardian. All minors will require guardian consent except for emancipated minors.
- AGYW not willing to test for HIV or HSV-2 or to receive test results.
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 |
|---|---|---|
| Cash TransferGirls enrolled receive a quarterly direct cash transfer of a total of 70,000 Tshs (30 USD) quarterly through mobile phone based cash transfer over a period of two years, for which they will receive mobile phones and SIM cards form the program. | Other | Intervention |
Primary outcome
HSV-2 Incidence
Time frame: 18 months of follow-up
Proportion of HSV-2 negative girls who are still free of HSV-2 across the two arms
3 secondary outcomes
HIV prevalence
Time frame: 18 months of follow-up
reporting of compensated sex
Time frame: 18 months of follow-up
reporting of intergenerational sexual partnerships
Time frame: 18 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 36121686Kuringe E, Christensen A, Materu J, Drake M, Majani E, Casalini C, Mjungu D, Mbita G, Kalage E, Komba A, Nyato D, Nnko S, Shao A, Changalucha J, Wambura M. Effectiveness of Cash Transfer Delivered Along With Combination HIV Prevention Interventions in Reducing the Risky Sexual Behavior of Adolescent Girls and Young Women in Tanzania: Cluster Randomized Controlled Trial. JMIR Public Health Surveill. 2022 Sep 19;8(9):e30372. doi: 10.2196/30372.
- Derived from this study: PubMed 31859686Wambura M, Drake M, Kuringe E, Majani E, Nyato D, Casalini C, Materu J, Mjungu D, Nnko S, Mbita G, Kalage E, Shao A, Changalucha J, Komba A. Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e14696. doi: 10.2196/14696.
- Derived from this study: PubMed 31593577Nyato D, Materu J, Kuringe E, Zoungrana J, Mjungu D, Lemwayi R, Majani E, Mtenga B, Nnko S, Munisi G, Shao A, Wambura M, Changalucha J, Drake M, Komba A. Prevalence and correlates of partner violence among adolescent girls and young women: Evidence from baseline data of a cluster randomised trial in Tanzania. PLoS One. 2019 Oct 8;14(10):e0222950. doi: 10.1371/journal.pone.0222950. eCollection 2019.
- Individual participant dataSharing planned: Yes. As part of the open data policy, all data emanating from this study will be shared with other researchers
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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.
Mwita Wambura, PhD principal investigator
NIMR Mwanza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash Transfer in people with HIV/AIDS and HSV-2 Infection, run by National Institute for Medical Research, Tanzania 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mwita Wambura, PhD (+255-28-2500399 ext. 261, wmwita@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HSV-2 Incidence (time frame: 18 months of follow-up). 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 NCT03597243, which also lists 3 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 26 Jul 2018.