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

12 de maio de 2026 atualizado por: Winfred K. Luseno, Pacific Institute for Research and Evaluation
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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

610

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Winfred (Winnie) K. Luseno, Ph.D.
  • Número de telefone: 919-265-2618
  • E-mail: wluseno@pire.org

Locais de estudo

  • Quênia
      • Nairobi, Quênia
        • Amref Health Africa in Kenya
        • Contato:
        • Investigador principal:
          • Anne M. Gitimu, MPPM, MPH

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Produto combinado: 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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Self-efficacy to abstain
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention

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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Knowledge about sexual and reproductive health
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Baseline and 6 months post-intervention
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
Prazo: Start-up of intervention through six-month intervention period
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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Acceptability of the Digital Champion strategy to promote/facilitate AskDoki access based on survey responses
Prazo: Immediately post-intervention
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.
Prazo: Start-up of intervention through six-month intervention period
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
Prazo: Start-up of intervention through six-month intervention period
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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pacific Institute for Research and Evaluation

Colaboradores

Fogarty International Center of the National Institute of Health
Michigan State University
Amref Health Africa

Investigadores

  • Investigador principal: Winfred (Winnie) K. Luseno, Ph.D., Pacific Institute for Research and Evaluation

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

22 de maio de 2026

Conclusão Primária (Estimado)

30 de abril de 2027

Conclusão do estudo (Estimado)

30 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1200
  • R21TW012623 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

The study will share the clinical trial survey data.

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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