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Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior - an Impact Evaluation (CARE)

Primary Purpose

HIV/AIDS, HSV-2 Infection

Status
Unknown status
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Cash Transfer
Sponsored by
National Institute for Medical Research, Tanzania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring Cash transfer, HIV, adolescent girls, Tanzania

Eligibility Criteria

15 Years - 23 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shinyanga regionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HSV-2 Incidence
Proportion of HSV-2 negative girls who are still free of HSV-2 across the two arms

Secondary Outcome Measures

HIV prevalence
HIV prevalence will be assessed by comparing the intervention arm against the control
reporting of compensated sex
Proportion of girls reporting compensated sex across the two arms
reporting of intergenerational sexual partnerships
Proportion of girls reporting intergenerational sexual partnerships across the two arms

Full Information

First Posted
July 13, 2018
Last Updated
July 24, 2018
Sponsor
National Institute for Medical Research, Tanzania
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1. Study Identification

Unique Protocol Identification Number
NCT03597243
Brief Title
Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior - an Impact Evaluation
Acronym
CARE
Official Title
Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behaviour - an Impact Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Anticipated)
Study Completion Date
December 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute for Medical Research, Tanzania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HSV-2 Infection
Keywords
Cash transfer, HIV, adolescent girls, Tanzania

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms parallel cluster randomized trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cash Transfer
Intervention Description
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.
Primary Outcome Measure Information:
Title
HSV-2 Incidence
Description
Proportion of HSV-2 negative girls who are still free of HSV-2 across the two arms
Time Frame
18 months of follow-up
Secondary Outcome Measure Information:
Title
HIV prevalence
Description
HIV prevalence will be assessed by comparing the intervention arm against the control
Time Frame
18 months of follow-up
Title
reporting of compensated sex
Description
Proportion of girls reporting compensated sex across the two arms
Time Frame
18 months of follow-up
Title
reporting of intergenerational sexual partnerships
Description
Proportion of girls reporting intergenerational sexual partnerships across the two arms
Time Frame
18 months of follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mwita Wambura, PhD
Phone
+255-28-2500399
Ext
261
Email
wmwita@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Evodius Kuringe, MD
Phone
+255-28-2500399
Email
evokur@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mwita Wambura, PhD
Organizational Affiliation
NIMR Mwanza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shinyanga region
City
Kahama
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Komba, MD
Phone
+255 22 2771346
Email
albert.komba@jhpiego.org
First Name & Middle Initial & Last Name & Degree
Gasper Mbita
Phone
+255 767 898 956
Email
Gaspar.Mbita@jhpiego.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
As part of the open data policy, all data emanating from this study will be shared with other researchers
IPD Sharing Time Frame
The IPD will shared during study closure
IPD Sharing Access Criteria
Will be determined by the funder and sponsor
Citations:
PubMed Identifier
36121686
Citation
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.
Results Reference
derived
PubMed Identifier
31859686
Citation
Wambura 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.
Results Reference
derived
PubMed Identifier
31593577
Citation
Nyato 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.
Results Reference
derived

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Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior - an Impact Evaluation

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