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

NCT07587281 | Not Yet Recruiting

• 2 other identifiers: 1200R21TW012623
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

mHealth Intervention

Keywords

Sex Education; Pregnancy in Adolescence; Sexually Transmitted Infections; Adolescent; Software; Prevention; Cell Phone; Sexual Health; Reproductive health; mHealth; Cost Effectiveness

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (6)

• Knowledge about sexual and reproductive health

  Baseline and 6 months post-intervention

• Self-reported STI symptoms

  Baseline and 6 months post-intervention

• Self-reported history of adolescent pregnancies

  Baseline and 6 months post-intervention

• Intention to test and treat STIs

  Baseline and 6 months post-intervention

• Intention to use SRH services

  Baseline and 6 months post-intervention

Other Outcomes (3)

• Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses

  Immediately post-intervention

• Cost per adolescent served.

  Start-up of intervention through six-month intervention period

• Cost per adolescent who makes progress on outcome measures

  Start-up of intervention through six-month intervention period

Study Arms (2)

AskDoki plus Digital Champions

EXPERIMENTAL

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

No access to AskDoki or Digital Champions

NO INTERVENTION

Adolescents in comparison communities do not receive access to the AskDoki chatbot or support from Digital Champions during the study period.

Interventions

Chatbot providing comprehensive sexuality education plus youth peer facilitators COMBINATION_PRODUCT

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.

AskDoki plus Digital Champions

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacific Institute for Research and Evaluation: lead
• Amref Health Africa: collaborator
• Michigan State University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Amref Health Africa in Kenya

Nairobi, Kenya

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Winfred (Winnie) K. Luseno, Ph.D.

  Pacific Institute for Research and Evaluation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Winfred (Winnie) K. Luseno, Ph.D.

CONTACT

919-265-2618; wluseno@pire.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: The study uses a quasi-experimental design with a nonequivalent control cluster.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 14, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

KE (1)