Adolescent sexual and reproductive health project
| ISRCTN | ISRCTN29711792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29711792 |
| Secondary identifying numbers | 108677-001 |
- Submission date
- 17/03/2024
- Registration date
- 20/03/2024
- Last edited
- 20/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
It is estimated that about 2 in 10 young women will become pregnant before 18 years of age worldwide. West Africa has the highest proportion of adolescent pregnancies (28%). These pregnancies are often unintended and impact negatively on the well-being of mother and child. The gap between sexual intentions and contraceptive behaviour (unmet need for contraceptives) is high among adolescents in Nigeria. There has been heightened awareness and action towards adolescent reproductive health in Nigeria. Nevertheless, the need to close the widening gap between sexual behaviour and contraceptive intentions still persist. This calls for well-designed interventions that draws from participation of all stakeholders to ensure ownership and sustainability, as well as set the pace for adolescent health action at subnational levels in Nigeria. The general aim of this study is to adapt, implement and evaluate an inclusive community-embedded intervention program to address unmet contraceptive need of adolescents in Ebonyi state.
Who can participate?
The study population are adolescents (males and females) ages 13-18 years in and out of secondary schools in rural and urban areas of Ebonyi state, Nigeria; parents and guardians of adolescents; and health professionals.
What does the study involve?
The study involved a situation analysis will be conducted to assess the SRH needs of adolescents. A comprehensive mapping of health determinants during the situation analysis and consultation with stakeholders resulted to the design and implementation of a multi-component intervention comprising, (i) Training of primary health care workers, community health workers and patent medicine providers to ensure that adolescents have access to quality SRH services; (ii) School-based interventions - peer education and school health club - to ensure that adolescents have access to and receive accurate information on SRH; and (iii) community sensitization campaigns - including media campaigns - to ensure community support for adolescent SRH, and promote parent-child communication of SRH matters.
What are the possible benefits and risks of participating?
The risk to human subjects from participating in the interviews was minimal. Participants that were concerned about the confidentiality of the information they provide, or those who experienced discomfort when responding to sensitive questions about sexual behaviour were managed well. Interviewers reminded participants that they could skip questions that cause discomfort and terminate the interview at any stage. Participants benefitted directly or indirectly from the interventions that were designed and implemented in their communities.
Where is the study run from?
The study was run from Health Policy Research Group in Ebonyi State, Nigeria.
When is the study starting and how long is it expected to run for?
March 2018 to March 2022
Who is funding the study?
International Development Research Centre, Canada
Who is the main contact?
Dr Chinyere Mbachu, chinyere.mbachu@unn.edu.ng
Contact information
Public
13/15 Leach Road
Abakaliki
480101
Nigeria
| Phone | +234 8033127633 |
|---|---|
| onwuamezenkechi@yahoo.com |
Principal Investigator
13/15 Leach Road
Abakaliki
480101
Nigeria
 ORCID ID |
0000-0003-3936-6184 |
|---|---|
| Phone | +234 8033401942 |
| chinyere.mbachu@unn.edu.ng |
Scientific
13/15 Leach Road
Abakaliki
480101
Nigeria
| Phone | +234 9069798391 |
|---|---|
| ifreda198@gmail.com |
Study information
| Study design | Non-randomized before and after intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, School |
| Study type | Prevention |
| Participant information sheet | 45197_PIS.pdf |
| Scientific title | Addressing unmet need for contraceptives among adolescents using a community-embedded intervention in Ebonyi state, Nigeria |
| Study acronym | ASRH |
| Study objectives | Multicomponent community-embedded interventions improve access to sexual and reproductive health information and health services for adolescents. |
| Ethics approval(s) |
Approved 13/03/2018, Health Research Ethics Committee, University of Nigeria Teaching Hospital (Enugu Port-Harcourt Expressway, Ituku-Ozalla, Enugu, 400001, Nigeria; +234 (042) 252022; cmdunth2011@yahoo.com), ref: UNTH/CSA/329/OL..5 |
| Health condition(s) or problem(s) studied | Sexual and Reproductive Health |
| Intervention | 1. Community-based interventions - (i) Training of formal and informal healthcare providers on the provision of adolescent-friendly sexual and reproductive health services; (ii) Community sensitization on the SRH needs and rights of adolescents - involving community leaders, parents and caregivers of adolescents 2. School-based interventions - (i) Establishment of school health clubs in public secondary schools; (ii) Training of peer health educators and teachers on the SRH needs and rights of adolescents; (iii) Distribution of IEC materials to secondary school students through the school health clubs. |
| Intervention type | Behavioural |
| Primary outcome measure | Unplanned pregnancies among adolescents measured using a questionnaire at baseline and endline |
| Secondary outcome measures | 1. Contraceptive prevalence rate among adolescents measured using a questionnaire at baseline and endline 2. Availability and provision of contraceptives and other SRH services for adolescents in primary health centers measured using data collected in patient notes at the end of the study 3. Availability and provision of contraceptives and other SRH services for adolescents in patent medicine stores measured using data collected in patient notes at the end of the study |
| Overall study start date | 13/03/2018 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Health professional, Learner/student, Population, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 13 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 1775 |
| Total final enrolment | 1763 |
| Key inclusion criteria | 1. Health professional - primary care providers of SRH services including frontline providers in primary health centers (formal providers), community health workers and patent medicine vendors (informal providers) 2. Learner/students - secondary school students in public/government-owned secondary schools 3. Population - community leaders and representatives, parents and guardian of adolescents aged 10-18, adolescents in communities 4. Service user - adolescents aged 13-18 years accessing SRH services from primary health centers, community health workers, and patent medicine vendors |
| Key exclusion criteria | 1. Adults and adolescents who had cognitive disabilities that preclude them from consenting or giving assent. Cognitive and other disabilities were assessed on a case-by-case basis. 2. Adolescents aged 13-14 years who were no longer under the care of a parent/guardian |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 14/06/2021 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Abakaliki
480101
Nigeria
Sponsor information
Research organisation
Health Policy Research Group, No 1 Old UNTH Site
Enugu
400001
Nigeria
| Phone | +234 803700771 |
|---|---|
| hprg@unn.edu.ng | |
| Website | https://www.unn.edu.ng/the-health-policy-research-group-hprg/ |
"ROR" |
https://ror.org/01sn1yx84 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Centre de recherches pour le développement international, IDRC, CRDI
- Location
- Canada
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analyzed during the current study have been stored in a publicly available repository (UK Data Service https://doi.org/10.5255/UKDA-SN-854374) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 18/03/2024 | No | No | ||
| Participant information sheet | 20/03/2024 | No | Yes | ||
| Protocol file | 20/03/2024 | No | No |
Additional files
Editorial Notes
18/03/2024: Trial's existence confirmed by Health Research Ethics Committee, University of Nigeria Teaching Hospital.
