Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior - an Impact Evaluation (CARE)
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|ClinicalTrials.gov Identifier: NCT03597243|
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS HSV-2 Infection||Other: Cash Transfer||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two arms parallel cluster randomized trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behaviour - an Impact Evaluation|
|Actual Study Start Date :||October 30, 2017|
|Estimated Primary Completion Date :||July 15, 2019|
|Estimated Study Completion Date :||December 15, 2019|
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.
Other: 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.
No Intervention: 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.
- 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
- HIV prevalence [ Time Frame: 18 months of follow-up ]HIV prevalence will be assessed by comparing the intervention arm against the control
- reporting of compensated sex [ Time Frame: 18 months of follow-up ]Proportion of girls reporting compensated sex across the two arms
- reporting of intergenerational sexual partnerships [ Time Frame: 18 months of follow-up ]Proportion of girls reporting intergenerational sexual partnerships across the two arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597243
|Contact: Mwita Wambura, PhD||+255-28-2500399 ext firstname.lastname@example.org|
|Contact: Evodius Kuringe, MDemail@example.com|
|Contact: Albert Komba, MD +255 22 2771346 firstname.lastname@example.org|
|Contact: Gasper Mbita +255 767 898 956 Gaspar.Mbita@jhpiego.org|
|Principal Investigator:||Mwita Wambura, PhD||NIMR Mwanza|