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.: PACTR201906738029948 Date of Approval: 11/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effective strategies for increasing utilization of Adolescent Sexual Reproductive Health Services in Kenya
Official scientific title Effectiveness of a combined approach towards Improving Utilization of Adolescent Sexual Reproductive Health Services in Kisumu and Kakamega Counties, Kenya.
Brief summary describing the background and objectives of the trial Adolescent pregnancy continues to be a major problem in Kenya, with a teenage pregnancy rate of 18 % and an adolescent birth rate of 96 per 1,000 women (1). Despite this burden, adolescents’ access to and utilization to Sexual and Reproductive Health (SRH) services and information, is a gap that is yet to be fully addressed. Main objective: To determine the effectiveness of a combined model towards improving utilization of Adolescent Sexual Reproductive Health (ASRH) services in Kisumu and Kakamega counties, Kenya. Specific Objectives and Methodology: 1. To describe evidence-based approaches for delivery of Adolescent and Sexual Reproductive Health (ASRH) Services through a systematic review. A systematic desk review of secondary published data on ASRH will be undertaken covering 10 years - 2008-201. This review will be conducted on published literature databases (BIDS, Medline, PubMed, Hinari etc.) following key words or combinations: ASRH, adolescent, family planning, teen pregnancy, and contraceptives. 2. To describe the trends in coverage of reproductive health services for adolescents aged 15-19 years in Kenya, secondary analysis of the 2003, 2008/9 and 2014 Kenya Demographic Health Survey data will be undertaken. 3. To describe the barriers, facilitators, preferences and experiences towards uptake of ASRH services among adolescents in Kenya. Using a cross-sectional assessment, data will be collected through focus group discussions (FGDs). In-depth interviews and key informant interviews. The participants will be purposefully selected to a total of 116. 4. To determine/describe the level of knowledge, attitude, practices and healthcare seeking behavior of Adolescents towards ASRH services in Kisumu and Kakamega counties, Kenya. This will be established through a household survey targeting adolescent girls. A sample size of 990 participants will be interviewed a baseline and a similar number at endline, making a total of 1980. A multistage cluster sampling
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Adolescent Sexual Reproductive Health
Purpose of the trial Prevention
Anticipated trial start date 01/10/2019
Actual trial start date
Anticipated date of last follow up 30/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 2840
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Non-randomised 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 Delivery of ASRH interventions using a combined approach Health Facility services - regularly Community outreach services - monthly Appropriate School interventions - monthly 18 months a) Biomedical approach – Provision of ASRH services to adolescents such as Family planning services b) Behavioral approach – Counselling and Provision of age appropriate comprehensive sexual education for social behavior change. This will include targeted training to health providers to provide Adolescent sensitive services using the Value Clarification and Attitude Transformation approach (VCAT). ASRH Services will be provided at health facility, communities, and in schools as appropriate. Social behavior change will be incorporated across all platforms 1478
Control Group Delivery of ASRH services using the routine health care system at health facilities Regular health facility working hours 18 months a) Biomedical approach – Provision of ASRH services to adolescents such as Family planning services b) Behavioral approach – Counselling and Provision of age appropriate comprehensive sexual education for social behavior change. ASRH Services including family planning, will be provided regularly at health facilities only 1362 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 15-19 years girls - Committed to reside in study area for the entire duration of the study - Consent provided by adolescents over 18 years and emancipated adolescents - Parental permission provided for minors (15-17) and informed assent by provided by the minors - When either informed consent (emancipated minors) or parental permission and informed assent (non-emancipated minors) is not provided as applicable - Adolescents who have already had a first birth or are pregnant - Adolescents in foster care - Adolescents with mental disability - Individuals unable to consent on their own or unwilling to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 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 20/02/2019 KEMRI
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road, Nairobi Nairobi 00200 Kenya
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 25/04/2019 John Hopkins JHSPH Institutional Review Board Office
Ethics Committee Address
Street address City Postal code Country
615 N. Wolfe Street / Room E1100 Baltimore, Nairobi 21205217 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Utilization of Family planning services among adolescents At baseline and end-line . Monthly progress check will also be done using routine health system data
Secondary Outcome Teenage pregnancy rates At baseline and Endline, using DHS data and routine health system data
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jhpiego office in Kisumu Milimani road Kisumu Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
JHPIEGO Kenya. JHPIEGO is an affiliate of John Hopkins University 14 riverside drive Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor USAID Kenya and East Africa UN avenue Gigiri Nairobi Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Dickens Onyango Director Ministry of Health Kisumu County Uhuru road Kisumu Kenya
Dr Beatrice Etemesi Chief Officer Health Kakamega County Kisumu Mumias Road Kakamega Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Susan Ontiri Susan.ontiri@jhpiego.org +254722605160 14 riverside drive
City Postal code Country Position/Affiliation
Nairobi Kenya Jhpiego
Role Name Email Phone Street address
Principal Investigator Lilian Mutea Lmutea@usaid.gov +254722676753 US Embassy-UN avenue Gigiri
City Postal code Country Position/Affiliation
Nairobi Kenya USAID Kenya and East Africa
Role Name Email Phone Street address
Public Enquiries Susan Ontiri susan.ontiri@jhpiego.org +254722605160 14 riverside drive
City Postal code Country Position/Affiliation
Nairobi Kenya Jhpiego
Role Name Email Phone Street address
Scientific Enquiries Lilian Mutea Lmutea@usaid.gov +254722676753 US Embassy -UN Avenue gigiri
City Postal code Country Position/Affiliation
Nairobi Kenya USAID Kenya and East Africa
Role Name Email Phone Street address
Principal Investigator Mark Kabue Mmkabue@gmail.com +14439286475 Baltimore
City Postal code Country Position/Affiliation
Baltimore Kenya USAID Kenya and East Africa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is a plan to make IPD and related data dictionaries available Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months post completion of the study Controlled access for purposes of advancing medical research. Data can be re analyzed, validated or combined with other data from similar studies
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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