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.: PACTR201310000644325 Date of Approval: 13/09/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of short-term financial incentives on sexual behavior and HIV incidence among youth: Evidence from a randomized controlled trial in Lesotho
Official scientific title The impact of short-term financial incentives on sexual behavior and HIV incidence among youth: Evidence from a randomized controlled field trial in Lesotho
Brief summary describing the background and objectives of the trial The primary aim of this study is to evaluate whether short-term financial incentives, distributed though lotteries, can affect young individuals' sexual behavior, and thus reduce HIV incidence rates. We propose to conduct a randomized controlled trial to test whether adding a financial incentive, in the form of a lottery, to remain STI- negative to a standard HIV prevention program can promote safer sexual activity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Trichomonas, Syphilis
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/02/2010
Actual trial start date 01/02/2010
Anticipated date of last follow up 01/02/2013
Actual Last follow-up date 01/02/2013
Anticipated target sample size (number of participants) 3426
Actual target sample size (number of participants) 3026
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
n/a Lesotho Ministry of Health and Social Welfare
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 The random assignment to the control and treatment groups has been done in a transparent way, by drawing a marble from a bag, the color of which assigns each individual to one of the treatment groups or to the control group The random assignment was conducted in a transparent way (i.e. each participant drew the marble from a bag). Participants know their group assignment. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lottery Incentive 1 Lottery every four months 3 years: 2 years of intervention and 1 year as long term follow-up Participants are eligible to participate to a lottery draw and potentially win 1000 Malotis (approximately 100$) if tested negative for curable STIs every 4 months. If tested positive they receive free treatment for STIs. Individual receive sexual health counseling sessions, free HIV and STI testing and free counseling before and after each STI/HIV test and free male and female condoms. 967
Experimental Group Lottery Incentive 2 Lottery every four months 3 years: 2 years of intervention and 1 year as long term follow-up Participants are eligible to participate to a lottery draw and potentially win 500 malotis (approximately 50$) if tested negative for curable STIs every 4 months. If tested positive they receive free treatment for STIs. Individual receive sexual health counseling sessions, free HIV and STI testing and free counseling before and after each STI/HIV test and free male and female condoms. 852
Control Group No Lottery Incentive No Lottery 3 years Individuals receive sexual health counseling sessions, free HIV and STI testing, free STI treatment (for individuals tested positive), and free counseling before and after each STI/HIV test and free male and female condoms. None in the control group is eligible to participate to lottery draws. 1819
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Females and males aged 18-32 living in the selected 29 villages. Females and males not belonging to the 18-32 age range. 18 Year(s) 32 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 18/06/2009 Lesotho Ministry of Health and Social Welfare
Ethics Committee Address
Street address City Postal code Country
Maseru 100 Maseru P. O. Box 514 Lesotho
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 26/08/2009 Fondazione Istituto Nazionale Tumori
Ethics Committee Address
Street address City Postal code Country
Via Giacomo Veneziani, 1 Milano 20100 Italy
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HIV incidence after 1 year and after 2 years from the beginning of intervention
Secondary Outcome HIV prevalence after 1 year and after 2 years from the beginning of intervention
Secondary Outcome STIs prevalence after 1 year and after 2 years from the beginning of intervention
Secondary Outcome sexual behaviors (condom use, abstinence, extramarital sex, number of sexual partners) after 1 year and after 2 years from the beginning of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Leads Consultancy L.O.I.C Administrative Block - Behind Lesotho High School Maseru-Lesotho P.O. Box 15787 Lesotho
FUNDING SOURCES
Name of source Street address City Postal code Country
The World Bank 1818 H Street, NW Washington, DC 20433 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Damien de Walque (The World Bank) 1818 H Street, NW Washington, DC 20433 United States of America Funding Agency
Primary Sponsor Damien de Walque (The World Bank) 1818 H Street, NW Washington, DC 20433 United States of America Funding Agency
Primary Sponsor Jakob Svensson (IIES Stockholm University) IIES-Institute for International Economic Studies SE-106 91 Stockholm Sweden University
Primary Sponsor Martina Björkman Nyqvist (Stockholm School of Economics) Sveavägen 65 Stockholm Sweden University
Primary Sponsor Lucia Corno (Queen Mary, University of London) Francis Bancroft Building, Mile End Road E1 4NS London United Kingdom University
Primary Sponsor Jakob Svensson (IIES Stockholm University) IIES-Institute for International Economic Studies SE-106 91 Stockholm Sweden University
Primary Sponsor Martina Björkman Nyqvist (Stockholm School of Economics) Sveavägen 65 Stockholm Sweden University
Primary Sponsor Lucia Corno (Queen Mary, University of London) Francis Bancroft Building, Mile End Road E1 4NS London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Leads Consultancy L.O.I.C Administrative Block - Behind Lesotho High School Maseru-Lesotho P.O. Box 15787 Lesotho
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jakob Svensson jakob.svensson@iies.su.se (+46) 8 16 30 60 IIES-Institute for International Economic Studies SE-106 91
City Postal code Country Position/Affiliation
Stockholm Sweden Professor, Institute for International Economic Studies, SU
Role Name Email Phone Street address
Public Enquiries Martina Björkman Nyqvist Martina.Bjorkman.Nyqvist@hhs.se (+46) 8 736 9285 Sveavägen 65
City Postal code Country Position/Affiliation
Stockholm Sweden Assistant Professor, Stockholm School of Economics
Role Name Email Phone Street address
Scientific Enquiries Martina Björkman Nyqvist Martina.Bjorkman.Nyqvist@hhs.se (+46) 8 736 9285 Sveavägen 65
City Postal code Country Position/Affiliation
Stockholm Sweden Assistant Professor, Stockholm School of Economics
REPORTING
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