Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003008116 Date of Approval: 25/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ujana Salama: A Cash Plus Model on Youth Well-being and Safe, Healthy Transitions
Official scientific title A Cash Plus model for Safe Transitions to a Healthy and Productive Adulthood in Tanzania: Intervention and Impact Evaluation
Brief summary describing the background and objectives of the trial Background: Adolescents in Tanzania face a myriad of risks related to poverty, including early pregnancy and marriage, gender-based violence, HIV, and limited livelihood opportunities. As per 2015 an estimated 17.5 million Tanzanians were aged between 15 to 34 years, a number expected to double by 2035. Youth therefore present a unique window of opportunity, and investments in adolescence are often referred to as having a triple dividend with benefits today, in their future adult life, and in the next generation of children. Addressing the structural determinants of risk, including poverty and unemployment is vital in improving youth outcomes. Importantly, youth development is prominent in Tanzania's five-year development plan (2016-2020): Accelerate broad-based and inclusive economic growth that reduces poverty substantially and allows shared benefits among the majority of the people through increased productive capacities and job creation especially for the youth and disadvantaged groups. The Tanzania Cash- Plus study is aimed at improving the livelihood and sexual reproductive health of adolescents in resource poor settings to improve their transitions to adulthood. Findings will inform design of future iterations of the Government's social protection programming and provide innovative programmatic guidance and the safe transition to adulthood of Tanzanian youth so as to reach their full productive potential as healthy adults. Objectives: The current study aims to (1) implement a cash plus intervention focusing on livelihood enhancement and complemented with HIV prevention/treatment information, sexual reproductive health and rights (SRHR), and gender equity messaging targeted to youth with linkages to youth friendly HIV/SRH services and (2) provide rigorous evidence on the impacts of this intervention on youth well-being, violence reduction, and safe transitions to adulthood.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV, STIs,Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 22/04/2017
Actual trial start date 22/04/2017
Anticipated date of last follow up 22/04/2019
Actual Last follow-up date 03/03/2021
Anticipated target sample size (number of participants) 4950
Actual target sample size (number of participants) 2500
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
2017 91 NA 2017 61 Tanzania Commission for Science and Technology - COSTECH
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sexual reproductive health and rights and Livelihood enhancement 1 day per week for face-to-face training; monthly meetings during mentoring phase 18 months Intervention is targeted to youth aged 14-19 years and living in households participating in the government cash transfer program (Productive Social Safety Net; PSSN). PSSN implementers facilitated access to participating households and study team approached all PSSN households in eligible villages to interview all eligible youth. The intervention was comprised of implement a cash plus intervention focusing on12 weeks face-to-face training on livelihood enhancement and complemented with HIV prevention/treatment information, sexual reproductive health and rights (SRHR), and gender equity messaging; 9 months of mentoring; and asset transfer totaling 80 USD (disbursed in 1-2 tranches). Linkages to strengthened youth friendly HIV/SRH services are facilitated by mentors. Adolescent friendliness of government facilities in study areas was strengthened via trainings by the Ministry of Health, Community Development, Gender, Elderly and Children, with technical assistance from UNICEF 1186 Uncontrolled
Control Group Control group None 18 months Targeted youth aged 14-19 years and living in households participating in the government cash transfer program (Productive Social Safety Net). No intervention activity will be conducted in these control villages for the study duration; Control villages will receive treatment after completion (expected 2021) 1250 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Youth living in households that meet the poverty criteria (i.e., living in households receiving government cash transfer program (PSSN)) and 14 years and to 19 years of age Being below 14 years or above 19 years; Not living in the a registered poor household Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 14 Year(s) 19 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/03/2017 Tanzania Committee for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Ali Hassan Mwinyi Road, Kijitonyama (Sayansi ) COSTECH Building Dar es Salaam 14107 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ever pregnant transactional sex (12 months) first sex forced physical violence (12 months) violence reporting (12 months T0 is Baseline, T1 is 6-months post adolescent training sessions, T2 is 18-months post adolescent training
Secondary Outcome Mental health as measured by 1) number of depressive symptoms (10-item Centre for Epidemiological Studies-Depression Scale) Depressive symptoms on and 2) proportion exhibiting depressive symptomology (greater or equal than 10 on the 10-item Centre for Epidemiological Studies-Depression Scale) T0, T1, T2, T3
Primary Outcome Transactional sex (12 months, among sexually debuted youth) -Financial reasons motivated current or last relationship - Given money by current/most recent partner - Would leave relationship if not financially supported by partner T0, T1, T2, T3
Primary Outcome First forced sex T0, T1, T2, T3
Primary Outcome Experienced physical violence if responded yes to any of the following (12 months) (1) slapped or pushed; (2) hit with a fist (3) kicked or beat up; (4) choked or burned (5) threatened or attacked with a knife, gun or any other weapon T0, T1, T2, T3
Primary Outcome Violence reporting (12 months) - percentage who sought formal or informal help among those who reported physical or emotional violence T0, T1, T2, T3
Secondary Outcome Perpetrated physical violence if responded yes to any of the following (12 months) (1) slapped or pushed; (2) hit with a fist (3) kicked or beat up; (4) choked or burned (5) threatened or attacked with a knife, gun or any other weapon T1, T2, T3
Secondary Outcome Social support based on a modified version of the Multidimensional Scale of Perceived Social Support T0, T1, T2, T3
Secondary Outcome Locus of control (LOC) based on five items from Levenson’s multidimensional LOC scale T0, T1, T2, T3
Secondary Outcome Quality of life using a 10-point “Cantril's Ladder of Life Scale” T0, T1, T2, T3
Secondary Outcome Gender-equitable attitudes using 24 items from the Gender-Equitable Men (GEM) Scale T0, T1, T2, T3
Secondary Outcome Sexual violence (12 months): percentage of youth who reported someone a) touched them in a sexual way without their permission, b) physically forced them to have sexual intercourse or c) forced them to perform other sexual acts without their consent. T0, T1, T2, T3
Secondary Outcome Condom use at last sex (past 12 months, among sexually debuted youth) T0, T1, T2, T3
Secondary Outcome Ever married/cohabiting T0, T1, T2, T3
Secondary Outcome Hours spent in economic activities (past 7 days):including farm work for the household; livestock herding for the household; fishing for the household; work in the non-farm household business; paid work outside the household; participation in Public Works Program T0, T1, T2, T3
Secondary Outcome Hours spent in domestic chores (past day) including collecting water; collecting firewood or other fuel materials; collecting nuts or other tree fruits; taking care of children, cooking or cleaning; taking care of the elderly or sick household members T0, T1, T2, T3
Secondary Outcome Started a business (last 12 months) T3
Secondary Outcome Self-perceived stress (Enhanced livelihood distress index) T0, T1, T2, T3
Secondary Outcome Contraceptive knowledge: percentage of youth knowledgeable about any modern types of contraception; percentage of youth knowledge of where to access contraceptives T0, T1, T2, T3
Secondary Outcome Contraceptive use (past 12 months, among sexually debuted youth): percentage of youth who used any modern types of contraception, percentage of youth who reported using a condom at last sex T0, T1, T2, T3
Secondary Outcome HIV knowledge, including whether adolescents have heard about HIV, from what source, and whether they know HIV-related facts T0, T1, T2, T3
Secondary Outcome Percentage who reported visits to a health center for SRH services (past 12 months) T0, T1, T2, T3
Secondary Outcome Number of sexual partners (past 12 months, among sexually debuted youth) T0, T1, T2, T3
Secondary Outcome Concurrent sexual relationship (past 12 months, among sexually debuted youth) T0, T1, T2, T3
Secondary Outcome School attendance (currently attending at time of survey) T0, T1, T2, T3
Secondary Outcome School attainment (currently in school or completed Form IV) T0, T1, T2, T3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Households in Rungwe and Busokelo Districts Rungwe DC Mbeya 53502 Tanzania
Households in Mufindi and Mafinga districts Mufindi DC Iringa 53528 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
UNICEF Office of Research Piazza della Santissima Annunziata, 12 Firenze FI 50121 Italy
Oak Foundation Avenue Louis Casaï, 58 Cointrin 1216 Switzerland
Swedish Development Cooperation (SIDA) Valhallavägen 199 Stockholm SE-105 25 Sweden
Foreign Commonwealth and Development Office King Charles Street, Westminster London SW1A 2AH United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNICEF Piazza della Santissima Annunziata, 12 Florence 50121 Italy Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Tanzania Social Action Fund (TASAF) Kilwa/Malindi Street Dar es Salaam 11107 Tanzania
Tanzania Committee on AIDS (TACAIDS) Samora Avenue Dar es Salaam 11107 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tia Palermo tmpalermo@unicef.org +393203903590 Piazza della Santissima Annunziata, 12
City Postal code Country Position/Affiliation
Florence 50121 Italy Social Policy Specialist
Role Name Email Phone Street address
Public Enquiries Lusajo Kajula sajokm@gmail.com +255767339755 NMC Flat 3B, Mbezi Beach
City Postal code Country Position/Affiliation
Dar es Salaam 14121 Tanzania Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Tia Palermo tmpalermo@unicef.org +390552033282;ext=282 Piazza SS. Annunziata, 12
City Postal code Country Position/Affiliation
Florence 50122 Italy Social Policy Specialist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Study Protocol 12 months after government approval of final impact evaluation report Provided by researcher
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.unicef-irc.org/publications/943-a-cash-plus-model-for-safe-transitions-to-a-healthy-and-productive-adulthood-baseline.html No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information