Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2019-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reaching Adolescent Girls and Young Women Through Girl-Friendly Drug Vendors

NCT04045912

HIV Contraception

COMPLETED NA

Adolescent Wellness Visits in Tanzania

NCT05306938

HIV Testing Contraceptive Usage

COMPLETED NA

Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health

NCT03938818

Gender-Based Violence

COMPLETED NA

An Assessment of an HIV Prevention Intervention (Project AIM) Among Junior Secondary School Students in Eastern Botswana

NCT02455583

HIV

COMPLETED NA

Microfinance and Health Intervention Trial for Youth in Dar es Salaam, Tanzania

NCT01865383

Sexually Transmitted Infections Domestic Violence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

i) 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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV/AIDS HSV-2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms parallel cluster randomized trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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.

Group Type EXPERIMENTAL

Cash Transfer

Intervention Type OTHER

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cash Transfer

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No