Adaptation plays a critical role in implementation science (IS) by optimizing the fit of evidence-based interventions (EBIs) to local contexts and populations. Adaptation is especially relevant in digital health, where technologies, user preferences, and needs evolve rapidly. Yet, methodological approaches to guide and document adaptation processes are seldom included. Grounded in an IS framework, we describe a multi-phase process and results for the adaptation of a digital health intervention (DHI) for HIV prevention and treatment for sexual and gender minority (SGM) youth in Malawi, Kenya, Nigeria, and Zambia. Guided by the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, and Testing (ADAPT-ITT) model, we adapted the EBI HealthMpowerment (HMP) DHI for SGM youth. We conducted eight focus group discussions with SGM youth (N = 80) living with or at risk for HIV and four with other key experts (N = 29) to inform app adaptations. Rapid qualitative analyses were conducted, and the findings were summarized using the Mobile App Rating Scale. Subsequently, we conducted beta testing with 40 SGM youth to assess the app’s usability with the validated System Usability Scale. The data were collected from June 2024 to April 2025. Most HMP adaptations were within two domains of the Mobile App Rating Scale: Engagement and Information Quality. Engagement adaptations focused on increasing support and reducing provider response times through the app, along with added gamification. Information Quality adaptations focused on expanding resources (e.g., mental health, economic strengthening) and ensuring that healthcare referrals made via the app were to SGM-competent providers. Functionality enhancements included adding content in local languages and integrating WhatsApp. Data safety was prioritized and addressed by creating an emergency lockout code. For Subjective Quality, participants perceived the app favorably for its support for medication adherence. Results from the beta testing indicated a score of 70.0, indicating above-average usability. Modifications were made to the ADAPT-ITT model to embed consultations with key experts throughout the different phases. The HMP app was collaboratively and iteratively adapted with SGM youth and key partners. This methodological approach enhances HMP’s functionality, quality, and safety, increasing the likelihood of success in future trials and scale-up. NCT06350682. Registered on February 20, 2024. https://reporter.nih.gov/project-details/11373152
While COVID-19 mortality was relatively low in many Sub-Saharan African countries during the first wave of the pandemic, SARS-CoV-2 transmission was extensive. We hypothesized that female sex workers (FSWs) would be at enhanced risk of acquisition of this novel respiratory viral infection, due to intimate contact with multiple sexual partners and solicitation of clients in crowded venues. Here we describe the seroincidence, socio-behavioural associations and clinical outcomes of SARS-CoV-2 infection in Kenyan FSWs early in the pandemic. A longitudinal cohort of 1003 FSWs (257 living with HIV) from Nairobi, Kenya was enrolled in mid-2019, just prior to the pandemic, and plasma was available for SARS-CoV-2 serology from 827 participants at clinical follow up approximately one year later. Socio-behavioural and respiratory symptom data were collected by questionnaire. We examined the association of SARS-CoV-2 infection with socio-behavioural factors. Follow-up was a median of 201 days (range; 92-342 days) after the declaration of the COVID-19 pandemic in Kenya, and 229 (27.7%) participants were SARS-CoV-2 seropositive. Seroprevalence increased steadily with time from pandemic declaration. Infection was not associated with behavioural or demographic parameters but was strongly associated with time since start of the pandemic (p < 0.0001). Respiratory symptoms during the past 6 months were reported by almost two-thirds of participants (510/821; 62.1%), with SARS-CoV-2 infection specifically associated with self-reported difficulty breathing, dizziness, fever, loss of smell, myalgia, rhinorrhea, and odynophagia; approximately half of the cases were completely asymptomatic. HIV status was not associated with differences in SARS-CoV-2 seroincidence or symptoms, and no behavioural or sociodemographic associations of infection were apparent. Pre-pandemic serology demonstrated antibodies recognizing one of SARS-CoV-2 Spike, RBD, or N in 151/994 participants (15.2%), but these were not associated with protection against subsequent SARS-CoV-2 infection. Overall, SARS-CoV-2 seroincidence was high early in the pandemic among Nairobi-based FSWs, with no clear socio-behavioural associations of infection.
Female sex workers (FSWs) in sub-Saharan Africa commonly experience violence, mental health problems, and harmful substance use. Stressful life events can harm the functioning of the hypothalamic-pituitary-adrenal (HPA) axis, serving as a pathway to increased poor health, including HIV susceptibility through cortisol levels. In this paper, we examine changes in hair cortisol concentration (HCC) levels and associations with experiences of violence, mental health problems and harmful substance use among FSWs in Nairobi, Kenya. We used baseline and endline data from the Maisha Fiti study of FSWs in Nairobi. Participants reported recent violence, poor mental health, and harmful alcohol/substance use at both time points. Hair samples proximal to the scalp were collected to measure HCC levels determined by ELISA technique. We analysed data from 285 HIV-negative respondents who provided a 2 cm hair sample at baseline and endline. Multivariable linear regression models were used to assess the associations between the trajectory of the main exposure variables and the change in HCC levels at endline. Findings showed that HCC levels decreased significantly (p-value = 0.001) from baseline (mean HCC = 316 ng/g) to endline (mean HCC = 238.1 ng/g). Reported prevalence of violence, mental health problems and harmful alcohol/other substances decreased. There was evidence of associations between change in HCC at endline and the trajectories of physical violence (p-value = 0.007) and physical and/or sexual violence (p-value = 0.048). There was weak evidence of an association between the trajectory of exposure to emotional violence but no evidence of other associations. These findings suggest that physical violence and physical and/or sexual violence may lead to HPA axis dysfunction, possibly serving as a pathway linking violence to increased poor health, including HIV acquisition. However, further research with repeated measurements and a larger sample size is needed to examine the associations between violence, HCC levels, and HIV infection.
Globally, men who have sex with men (MSM) face significant sexual stigma and are at disproportionate risk of HIV and STIs. This cross-sectional study examined differences in HIV/STI-associated psychosocial characteristics and sexual behaviors among men who have sex with both men and women (MSMW) and men who have sex with men exclusively (MSME) in Kenya. MSM were categorized as either MSMW or MSME based on the reported sex of recent sexual partners. Depressive symptoms, alcohol use, and substance use were evaluated using the Patient Health Questionnaire 9 (PHQ-9), Alcohol Use Disorders Identification Test (AUDIT), and Drug Abuse Screening Test (DAST), respectively. Overall, 730 cisgender MSM were included in this analysis (405 MSMW and 325 MSME). MSMW reported twice as many partners as MSME in the last three months, while MSME were more likely to report engaging in receptive anal sex. MSMW were more likely to report hazardous alcohol and substance use. However, MSMW scored lower than MSME on the MSM Sexual Stigma Scale. These findings emphasize the need for socially aware, stigma-informed approaches that recognize how MSM may experience and manage sexual stigma differently, shaping their mental health, substance use, and sexual risk behaviors.
Background Men who have sex with men (MSM) are at high risk for bacterial sexually transmitted infections (STIs), including gonorrhea, chlamydia, and syphilis, in Kenya. Because nucleic acid amplification testing (NAAT) is not widely accessible, most gonorrhea and chlamydia infections go undiagnosed and are treated only if symptomatic. World Health Organization (WHO)–recommended periodic presumptive treatment (PPT) and doxycycline post-exposure prophylaxis (doxyPEP) are both potential interventions to reduce the burden of bacterial STIs in this population. Neither has been rigorously tested among MSM in Africa. Objective This study aims to evaluate the effectiveness of WHO-recommended PPT versus doxyPEP, compared with standard syndromic treatment, in reducing the prevalence of bacterial STIs, including gonorrhea, chlamydia, and syphilis, among MSM in Kenya. Methods We are conducting an open-label randomized controlled trial with 2900 participants assigned in a 2:2:1 ratio to WHO-recommended PPT given every 3 months, doxyPEP taken 24-72 hours after condomless sex, or standard treatment. Sociodemographic, psychosocial, and behavioral data are collected by audio computer-assisted self-interview. Syphilis testing and treatment are provided as part of standard care. Throat and rectal swabs and urine are collected, pooled, and batch tested for gonorrhea and chlamydia by NAAT; these results are not used to guide treatment. The primary trial outcome is the combined prevalence of laboratory-diagnosed gonorrhea, chlamydia, and early syphilis after baseline; secondary outcomes include the prevalence of each pathogen individually and antimicrobial resistance in Neisseria gonorrhoeae. Primary and secondary outcomes will be compared between each intervention and the common control arm by estimating relative risks over follow-up (months 3-18) using a modified Poisson model fitted with generalized estimating equations. We will also assess implementation outcomes, including acceptability, feasibility, and safety of each intervention compared to standard care among providers and patients using a mixed methods approach. Finally, we will evaluate the potential health and economic impact of scaling up WHO-recommended PPT and doxyPEP compared to standard of care on STI control among MSM and their partners in Kenya using a stochastic, network-based model and cost-effectiveness analysis on trial data. Results Enrollment commenced on October 29, 2025. As of November 25, 2025, a total of 357 participants (12.3% of target) have been enrolled, including 133 in Kisumu, 122 in Nairobi, and 102 in Mombasa. Full enrollment is expected to take 6 months, with follow-up occurring over 18 months per participant. Results will be published in 2028. Conclusions Results of this trial will provide critical data needed to inform guidelines to improve STI control among MSM in sub-Saharan Africa and other resource-limited settings where NAAT is not routinely available. Modeled estimates of the health and economic impact of scaling up these two interventions on STI control among MSM and their partners in Kenya will provide critical information to guide policymakers considering adoption of either intervention. Trial Registration ClinicalTrials.gov NCT06468462; https://clinicaltrials.gov/ct2/show/NCT06468462 International Registered Report Identifier (IRRID) PRR1-10.2196/81113
