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Not yet recruiting NCT07587281

Evaluation of a Mobile Health Intervention to Improve Sexual and Reproductive Health Outcomes Among Kenyan Adolescents Living in Urban Informal Settlements

No phase Interventional mHealth Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chatbot providing comprehensive sexuality education plus youth peer facilitators.
Who it may be relevant to
Registry conditions: mHealth Intervention. Basic parameters: 15 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Kenya
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This two-year study evaluates a mobile phone-based comprehensive sexuality education program designed to support adolescent sexual and reproductive health in Kenya, where rates of teenage pregnancy and sexually transmitted infections remain high. The program, called AskDoki, delivers age-appropriate health information through the WhatsApp platform and is supported by trained youth peer leaders known as Digital Champions, who help adolescents access and use the program. Communities participating in the study are assigned either to receive the AskDoki program with Digital Champion support (intervention communities) or to not receive the program (comparison communities). Adolescents in both intervention and comparison communities complete surveys before the program begins and again six months after implementation of the AskDoki program. The surveys assess health knowledge, attitudes, perceptions, and intended behaviors related to sexual and reproductive health. The study compares changes in survey responses over time between intervention and comparison communities to assess the program's effectiveness. It also evaluates how feasible it is to use Digital Champions to support adolescents' engagement with the mobile program and examines the cost-effectiveness of this approach.

Detailed description

Despite recent improvements in adolescent sexual and reproductive health outcomes in Kenya, rates of unsafe sex, unintended pregnancy, abortion, and sexually transmitted infections remain high. School based comprehensive sexuality education has been shown to improve adolescent sexual and reproductive health outcomes; however, implementation in Kenya is often limited by curriculum constraints and challenges faced by teachers, including limited time, training, and resources. As a result, many adolescents lack access to adequate sexuality education outside the formal school setting. Mobile health technology may offer a cost effective approach to delivering comprehensive sexuality education to adolescents. Amref Health Africa in Kenya developed and pilot tested a mobile, WhatsApp based artificial intelligence chatbot called AskDoki, designed to provide age appropriate comprehensive sexuality education. Preliminary findings suggested that pairing the digital curriculum with trained youth peer leaders-referred to as Digital Champions-may enhance reach, engagement, and effectiveness, particularly among adolescents with limited access to personal mobile devices. Pacific Institute for Research and Evaluation (PIRE), in collaboration with Amref Health Africa, is implementing AskDoki in urban informal settlements in Kenya using a community based approach. The study uses a quasi experimental design in which communities are assigned either to receive the AskDoki program supported by Digital Champions or to serve as comparison communities without access to the intervention. Adolescents aged 15 to 19 years complete surveys at baseline and six months after program implementation. The study evaluates changes over time in key determinants of sexual and reproductive health behaviors, including knowledge, attitudes, perceptions, self efficacy, and behavioral intentions, and compares outcomes between intervention and comparison communities. In addition, the study includes a process evaluation to assess the feasibility, acceptability, and implementation of the Digital Champion strategy. A cost effectiveness analysis is conducted to estimate the cost per adolescent reached and the cost per adolescent achieving improvements in key outcomes.

Interventions

  • Combination product Chatbot providing comprehensive sexuality education plus youth peer facilitators
    A chatbot designed to provide comprehensive sexuality education (named "AskDoki") to adolescents is deployed in a community targeted to receive the intervention along with peer facilitators. The facilitators are young adults (named "Digital Champions") who are trained to promote and facilitate access and use among adolescents of a chatbot.

Primary outcome measures

  • Self-efficacy to abstain [Time frame: Baseline and 6 months post-intervention]
  • Sexual self-efficacy [Time frame: Baseline and 6 months post-intervention]
  • Perceived advantages of delaying sex [Time frame: Baseline and 6 months post-intervention]
  • Perceived disadvantages of delaying sex [Time frame: Baseline and 6 months post-intervention]
  • Attitudes towards condoms [Time frame: Baseline and 6 months post-intervention]
  • Perceived norms of delaying sex [Time frame: Baseline and 6 months post-intervention]
  • Subjective norms about condoms [Time frame: Baseline and 6 months post-intervention]
  • Intention to abstain from sex [Time frame: Baseline and 6 months post-intervention]
  • Intentions to use condoms [Time frame: Baseline and 6 months post-intervention]
  • Sexual Behavior [Time frame: Baseline and 6 months post-intervention]
Secondary outcome measures (6)
  • Knowledge about sexual and reproductive health [Time frame: Baseline and 6 months post-intervention]
  • Self-reported STI symptoms [Time frame: Baseline and 6 months post-intervention]
  • Self-reported history of adolescent pregnancies [Time frame: Baseline and 6 months post-intervention]
  • Intention to test and treat STIs [Time frame: Baseline and 6 months post-intervention]
  • Intention to use SRH services [Time frame: Baseline and 6 months post-intervention]
  • Retention of Digital Champions [Time frame: Start-up of intervention through six-month intervention period]

Eligibility criteria

Adolescent participants

Inclusion criteria

  • age 15-19
  • residing in one of the informal settlements participating in the study
  • not planning to relocate for 18 months
  • not currently married or living as married
  • comprehension of informed consent
  • willing to provide assent/consent

Exclusion criteria

  • Age 14 and younger
  • Age 20 and older
  • Married/living as married
  • Planning to relocate within 18 months
  • Not residing in one of the informal settlements participating in the study
  • Unable to comprehend informed consent
  • Unwilling to provide assent/consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Kenya · 1 center
  • Amref Health Africa in Kenya — Nairobi

Identifiers

NCT: NCT07587281 · 1200 · R21TW012623

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗