NCT03597243

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

July 13, 2018

Last Update Submit

July 24, 2018

Conditions

HIV/AIDSHSV-2 Infection

Keywords

Cash transferHIVadolescent girlsTanzania

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • HIV prevalence

    18 months of follow-up

  • reporting of compensated sex

    18 months of follow-up

  • reporting of intergenerational sexual partnerships

    18 months of follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Cash TransferOTHER

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

Eligibility Criteria

Age15 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinyanga region

Kahama, Tanzania

RECRUITING

Related Publications (3)

  • 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.

    PMID: 36121686DERIVED

  • 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.

    PMID: 31859686DERIVED

  • 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.

    PMID: 31593577DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Mwita Wambura, PhD

    NIMR Mwanza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mwita Wambura, PhD

CONTACT

+255-28-2500399wmwita@yahoo.com

Evodius Kuringe, MD

CONTACT

+255-28-2500399evokur@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two arms parallel cluster randomized trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research Scientist

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 24, 2018

Study Start

October 30, 2017

Primary Completion

July 15, 2019

Study Completion

December 15, 2019

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

As part of the open data policy, all data emanating from this study will be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The IPD will shared during study closure
Access Criteria
Will be determined by the funder and sponsor

Locations

TA(1)