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

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.

Study Overview

• Status: Unknown
• Conditions: HIV/AIDS; HSV-2 Infection
• Intervention / Treatment: Other: Cash Transfer

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
• Enrollment (Anticipated): 3120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mwita Wambura, PhD; Phone Number: 261 +255-28-2500399; Email: wmwita@yahoo.com
• Study Contact Backup: Name: Evodius Kuringe, MD; Phone Number: +255-28-2500399; Email: evokur@gmail.com

Study Locations

• Tanzania
  • Kahama, Tanzania
    • Recruiting
    • Shinyanga region
    • Contact: Albert Komba, MD; Phone Number: +255 22 2771346; Email: albert.komba@jhpiego.org
    • Contact: Gasper Mbita; Phone Number: +255 767 898 956; Email: Gaspar.Mbita@jhpiego.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 23 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HSV-2 Incidence	Proportion of HSV-2 negative girls who are still free of HSV-2 across the two arms	18 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV prevalence	HIV prevalence will be assessed by comparing the intervention arm against the control	18 months of follow-up
reporting of compensated sex	Proportion of girls reporting compensated sex across the two arms	18 months of follow-up
reporting of intergenerational sexual partnerships	Proportion of girls reporting intergenerational sexual partnerships across the two arms	18 months of follow-up

Collaborators and Investigators

• Sponsor: National Institute for Medical Research, Tanzania
• Investigators: Principal Investigator: Mwita Wambura, PhD, NIMR Mwanza

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2017
• Primary Completion (ANTICIPATED): July 15, 2019
• Study Completion (ANTICIPATED): December 15, 2019

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (ACTUAL): July 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: HIV; Tanzania; adolescent girls; Cash transfer
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 16.01.CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No