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Trial record 18 of 39 for:    ("sex behavior" OR "sexual behavior" OR "sex risk behavior") AND (teen OR adolescent) AND HIV risk | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Information provided by (Responsible Party):
Mwita Wambura, National Institute for Medical Research, Tanzania

Brief 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 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS HSV-2 Infection Other: Cash Transfer Not Applicable

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:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arms parallel cluster randomized trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. HIV prevalence [ Time Frame: 18 months of follow-up ]
    HIV prevalence will be assessed by comparing the intervention arm against the control

  2. reporting of compensated sex [ Time Frame: 18 months of follow-up ]
    Proportion of girls reporting compensated sex across the two arms

  3. reporting of intergenerational sexual partnerships [ Time Frame: 18 months of follow-up ]
    Proportion of girls reporting intergenerational sexual partnerships across the two arms



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Mwita Wambura, PhD +255-28-2500399 ext 261 wmwita@yahoo.com
Contact: Evodius Kuringe, MD +255-28-2500399 evokur@gmail.com

Locations
Tanzania
Shinyanga region Recruiting
Kahama, Tanzania
Contact: Albert Komba, MD    +255 22 2771346    albert.komba@jhpiego.org   
Contact: Gasper Mbita    +255 767 898 956    Gaspar.Mbita@jhpiego.org   
Sponsors and Collaborators
National Institute for Medical Research, Tanzania
Investigators
Principal Investigator: Mwita Wambura, PhD NIMR Mwanza

Responsible Party: Mwita Wambura, Principal Research Scientist, National Institute for Medical Research, Tanzania
ClinicalTrials.gov Identifier: NCT03597243     History of Changes
Other Study ID Numbers: 16.01.CT
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As part of the open data policy, all data emanating from this study will be shared with other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The IPD will shared during study closure
Access Criteria: Will be determined by the funder and sponsor

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mwita Wambura, National Institute for Medical Research, Tanzania:
Cash transfer
HIV
adolescent girls
Tanzania