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.: PACTR202012522031174 Date of Approval: 11/12/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Peer-referral intervention to increase uptake of family planning services among adolescent women in Uganda
Official scientific title Impact of a behavioral intervention to increase informed decisions to uptake family planning services among adolescent women in Uganda: A randomized controlled evaluation
Brief summary describing the background and objectives of the trial An unplanned pregnancy during adolescence can dramatically impact a girl’s health and economic future. About 11% of all births worldwide are to adolescent girls; complications from pregnancy and childbirth are the leading cause of death for girls aged 15-19 (WHO, 2018). Surveys in Sub-Saharan African countries find that nearly all adolescent girls who have ever been pregnant are out of school, with pregnancy cited as the most common reason for drop out (Birungi et al., 2015). In Uganda, 25% of adolescent girls aged 15-19 had begun childbearing in 2016, yet nearly half of births were reported as mistimed or unwanted – a higher proportion than in older women (UBOS 2016). Of the 2.5 million adolescent girls aged 15-19 in Uganda, 26% are sexually active and do not want a child for at least two years (Guttmacher Institute, 2018). However, only 39% of those girls are using modern contraception, leaving six in ten with an unmet need for modern contraception. Increased efforts are needed to ensure that contraception is not only available to adolescents but that they can access services and are provided youth-friendly counseling to support their informed choice. Interventions aimed at adolescents who are still forming their identities and developing their understanding of norms around sexuality and gender may be especially critical in contexts where social stigma can be a barrier to contraception uptake. Among this age group, peers can be especially influential on romantic and sexual behaviors. In this study we evaluate a novel, behaviorally designed intervention to increase adolescent uptake of FP counseling and services in Uganda.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Uptake of family planning services
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Behavioral intervention
Anticipated trial start date 01/02/2020
Actual trial start date 01/02/2020
Anticipated date of last follow up 31/10/2020
Actual Last follow-up date 31/10/2020
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 116
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Core Intervention Intervention was implemented at clinic-level 6 months The core intervention is primarily a peer-referral system, intended to reduce stigma and normalize adolescent information sharing and service uptake. The program allows girls aged 15-19 who use contraceptives or have received contraceptive counseling to offer a “Refer-a-Friend” (RAF) card they received from a provider or mobilizer to a friend who is not currently using contraceptives. Girls can redeem their RAF card at a BlueStar clinic for a pair of friendship wristbands – one for her and one for the friend who referred her – and free contraceptive counselling if she is interested. Girls are not required to accept counseling or take up an FP method to receive the wristbands. Clinic providers are instructed to provide wristbands upfront once a girl presents a RAF card so they don’t feel pressured to stay for FP services. RAF cards can be redeemed regardless of whether girls have vouchers for a method. When a girl visits a clinic to redeem a card, she receives a new card to give to another friend, becoming an advice-giver herself. In-facility materials, including posters welcoming adolescent girls and displaying redeemed RAF cards, as well as feedback mechanisms for staff, help to create an adolescent-friendly environment. 31
Experimental Group Core Plus Intervention Intervention was implemented at clinic-level 6 months Same as Core Intervention, but clinic providers additionally received a 3-day standard training in youth-friendly service provision. 35
Control Group Control No treatment 6 months Clinics operate under business as usual, do not receive intervention materials or training 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Social Franchise clinics active in Marie Stopes Uganda's BlueStar network Clients of BlueStar clinics who are adolescent girls aged 15-19 (no individual-level data collection) Social Franchise clinics suspended from the BlueStar network Social Franchise clinics new to the BlueStar network and missing pre-intervention administrative data Adolescent: 13 Year-18 Year 15 Year(s) 19 Year(s) Female
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 28/02/2020 The AIDS Support Organization TASO IRB
Ethics Committee Address
Street address City Postal code Country
National Referral Hospital- Mulago, Opposite the Psychiatry Ward. P.O. Box 10443 Kampala Box 10443 Uganda
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 09/12/2019 MSI Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
1 Conway St, Fitzroy Square London W1T 6LP United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of adolescents who visited the clinic for family planning services Monthly
Primary Outcome Adolescent proportion of clients who visited the clinic for family planning services Monthly
Secondary Outcome Number of young adult women aged 20-24 who visited the clinic for family planning services Monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Marie Stopes Uganda Plot No. 1020, Kisugu-Muyenga, PO Box 10431 Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Hewlett Foundation 2121 Sand Hill Road Menlo Park CA 94025 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ideas42 80 Broad St, 30th Fl New York 10004 United States of America Non-profit research organization
Primary Sponsor Marie Stopes Uganda Plot 1020, Kisugu-Muyenga Kampala Uganda Implementing NGO
COLLABORATORS
Name Street address City Postal code Country
MSI Reproductive Choices 1 Conway Street, Fitzroy Square London W1T 6LP United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sara Flanagan sara@ideas42.org +14145593608 80 Broad St, 30th Fl
City Postal code Country Position/Affiliation
New York 10004 United States of America Vice President ideas42
Role Name Email Phone Street address
Scientific Enquiries Sara Flanagan sara@ideas42.org +14145593608 80 Broad St, 30th Fl
City Postal code Country Position/Affiliation
New York 10004 United States of America Vice President ideas42
Role Name Email Phone Street address
Public Enquiries Sara Flanagan sara@ideas42.org +14145593608 80 Broad St, 30th Fl
City Postal code Country Position/Affiliation
New York 10004 United States of America Vice President ideas42
Role Name Email Phone Street address
Principal Investigator Andrew Gidudu andrew.gidudu@mariestopes.or.ug +256414347129 Plot 1020, Kisugu-Muyenga
City Postal code Country Position/Affiliation
Kampala Uganda Head of Research Monitoring and Evaluation Marie Stopes Uganda
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This study was not a clinical trial and we did not collect individual participant data. The study evaluates the impact of an intervention based on summary outcomes captured through clinic-level administrative data. Facility administrative data is confidential; however, summary results will be published and linked within this trial registration record. Study Protocol Study results will be shared within 12 months. Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/12/2021 01/11/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 01/12/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information