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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: mHealth Intervention
• Intervention / Treatment: Combination product: Chatbot providing comprehensive sexuality education plus youth peer facilitators

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.

• Study Type: Interventional
• Enrollment (Estimated): 610
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Winfred (Winnie) K. Luseno, Ph.D.; Phone Number: 919-265-2618; Email: wluseno@pire.org

Study Locations

• Kenya
  • Nairobi, Kenya
    • Amref Health Africa in Kenya
    • Contact: Anne M. Gitimu, MPH, MPPM; Phone Number: +254721947017; Email: anne.gitimu@amref.org
    • Principal Investigator: Anne M. Gitimu, MPPM, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AskDoki plus Digital Champions; Intervention communities receive access to the AskDoki WhatsApp chatbot delivering comprehensive sexuality education, with support from trained youth peer leaders ("Digital Champions") who facilitate adolescent engagement with the program.	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.
No Intervention: No access to AskDoki or Digital Champions; Adolescents in comparison communities do not receive access to the AskDoki chatbot or support from Digital Champions during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy to abstain	Change in respondents' confidence in their ability to abstain from sex. Example item: "I can refuse sex when I don't feel like having sex." Five summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).	Baseline and 6 months post-intervention
Sexual self-efficacy	Change in respondents' confidence to negotiate and use condoms. Example item: "I can negotiate condom use with a potential partner". Eight summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).	Baseline and 6 months post-intervention
Perceived advantages of delaying sex	Change in respondents' perceptions about the advantages of delaying sex. Example item: "Waiting until I am older before I have sex will… Help me achieve my life's goals." Five summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).	Baseline and 6 months post-intervention
Perceived disadvantages of delaying sex	Change in respondents' perceptions about the disadvantages of delaying sex. Example item: "Waiting until I am older before I have sex will… Make me look old-fashioned." Four summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).	Baseline and 6 months post-intervention
Attitudes towards condoms	Change in respondents' perceptions about condom use. Example item: "It is OK to use condoms." Five summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).	Baseline and 6 months post-intervention
Perceived norms of delaying sex	Change in respondents' beliefs about perceived norms among people in one's life (friends, parents, other family, boyfriend/girlfriend) concerning delaying sex. Example item: "Most of my friends think that I should wait until I am older before I have sex." Four summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).	Baseline and 6 months post-intervention
Subjective norms about condoms	Change in respondents' beliefs about perceived norms among people in one's life (friends, parents, other family, boyfriend/girlfriend) concerning condoms. Example item: "My friends think that I should carry a condom." Four summed items. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree).	Baseline and 6 months post-intervention
Intention to abstain from sex	Change in respondents' intention to have sex within next month, 6 months, a year. Example item: "I intend to have sex within the next month." Three items summed and averaged. Response options are on a 5-point Likert scale (Strongly disagree to Strongly agree). Responses are inversely coded to reflect intention to abstain from sex.	Baseline and 6 months post-intervention
Intentions to use condoms	Change in respondents' intention to use a condom during sexual intercourse. Single item: "I plan to use a condom when I have sexual intercourse." Response options are on a 5-point Likert scale (Strongly disagree to strongly agree).	Baseline and 6 months post-intervention
Sexual Behavior	Change in respondents' sexual behavior. Example item: "Have you had vaginal sex with anyone in the past 6 months?" (yes/no). Three items to assess any sexual activity (i.e., anal, oral, and vaginal sex).	Baseline and 6 months post-intervention
Frequency of sexual activity	Change in how often respondents had sex in past month. Single item: "In the past month, how frequently did you have sex?" Five response options from "Zero times" to "More than four times a week."	Baseline and 6 months post-intervention
Condom use at last sex	Condom used at last sex reported in survey. Single item: "Did you or your partner use a condom the last time your had sex?" (yes/no).	Baseline and 6 months post-intervention
Condom use consistency	Condom use frequency reported in survey. Single item: "In the past month, how frequently did you use a condom when having sex?" Five response options ("Never, none of the time" to "Always, every time").	Baseline and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge about sexual and reproductive health	Measures change in knowledge about sexually transmitted infections (STIs), sexual behavior, and pregnancy. Example item: "Can a person who looks strong and healthy be HIV positive?" (yes/no) Items will be summed and averaged.	Baseline and 6 months post-intervention
Self-reported STI symptoms	Respondents' self-reported STI symptoms. Example item: "Do you currently have any of the following symptoms?... Sore or lesions in your genital area or anus" (yes/no). Six items will be used to derive prevalence and distribution of STI symptoms.	Baseline and 6 months post-intervention
Self-reported history of adolescent pregnancies	Respondents' self-reported history of pregnancy and impregnating someone. Example item: "Are you or your partner currently pregnant?""	Baseline and 6 months post-intervention
Intention to test and treat STIs	Two survey items assessing intentions to test and treat STIs. Example item: "I plan to visit a clinic to test for STIs if I have symptoms." Two summed items. Response options are on a 5-point Likert scale (Strongly disagree to strongly agree). Items were newly created for this study.	Baseline and 6 months post-intervention
Intention to use SRH services	Increase in intention to use SRH services. Single item: "I plan to visit a clinic for family planning services." Response options are on a 5-point Likert scale (Strongly disagree to strongly agree). Item was newly created for this study.	Baseline and 6 months post-intervention
Retention of Digital Champions	Percent of Digital Champions retained (number retained at end of intervention period divided by total number hired) based on program administration records.	Start-up of intervention through six-month intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses	Average of 6 items about acceptability on post intervention survey. Example item: "Overall, how acceptable did you find the Digital Champions?" Response options are on a 5-point Likert scale. Items were adapted from a questionnaire based on the Theoretical Framework of Acceptability.	Immediately post-intervention
Cost per adolescent served.	Cost effectiveness is computed as the cost of intervention divided by the number of adolescents served. Program cost data will be obtained from labor costs of program and Digital Champion staff in addition to other AskDoki program costs.	Start-up of intervention through six-month intervention period
Cost per adolescent who makes progress on outcome measures	Cost per adolescent who makes progress on outcome measures. Cost effectiveness is computed as the cost of intervention divided by the number of positive outcomes. The cost effectiveness ratios we compute will depend on what outcomes increase significantly relative to the comparison group. Program cost data will be obtained from labor costs of program and Digital Champion staff in addition to other AskDoki program costs.	Start-up of intervention through six-month intervention period

Collaborators and Investigators

• Sponsor: Pacific Institute for Research and Evaluation
• Collaborators: Fogarty International Center of the National Institute of Health; Michigan State University; Amref Health Africa
• Investigators: Principal Investigator: Winfred (Winnie) K. Luseno, Ph.D., Pacific Institute for Research and Evaluation

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Prevention; Cost Effectiveness; mHealth; Reproductive health; Software; Sexual Health; Pregnancy in Adolescence; Sexually Transmitted Infections; Sex Education; Cell Phone
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases
• Other Study ID Numbers: 1200; R21TW012623 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study will share the clinical trial survey data.
• IPD Sharing Time Frame: Data will be made available once analysis is completed or at the time of associated publication. The duration of preservation and sharing of the data will be a minimum of 5 years after the funding period.
• IPD Sharing Access Criteria: The data shared will be made available to researchers at other institutions only per PIRE Institutional Review Board (IRB) approval and after the study is completed and primary findings are published. The rights and privacy of participants will be protected by: (a) IRB review and approval of data sharing activities and (b) releasing only de-identified data. De-identified data will include no information that could link it to individual participants. It is the policy of the PIRE IRB to not share data that are personally identifiable or could lead to disclosure of the identities of individual subjects. Moreover, we will not share data that could cause significant social or legal harm to research participants. Data will be shared for quantitative analyses of primary outcome measures. The dataset(s) that we share will be deposited in a repository such as openICPSR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No