Sexual behaviour among Kenyan adolescents enrolled in an efficacy trial of a smartphone game to prevent HIV: a cross-sectional analysis of baseline data.

Sexual behaviour of adolescents is contextual, with various determinants affecting sexual activity and age of sexual debut. Insight into sexual activity among young adolescents has the potential to influence appropriate sexual and reproductive health interventions. For this analysis, adolescents were recruited as part of the Tumaini smartphone game efficacy trial. Data collection included a self-administered behavioural survey and blood test for HIV and HSV-2. Descriptive statistics were calculated for demographics and measures of sexual behaviour and behavioural intent based on gender and sexual experience, with associations assessed using chi-square tests, t-tests and Wilcoxon rank sum tests as appropriate. We enrolled 996 adolescents, mean age 14 years and 2.2% HSV-2 positivity. Overall, 15% of the adolescents were sexually experienced, this being associated with lower socio-economic status (p = 0.01), household food insecurity (p = 0.008), a living situation without both parents (p < 0.01), substance use (p = 0.02), no adult conversation about future goals (p = 0.003), conversations about condoms (p = 0.01), with some gender disparity within these factors. Among those sexually experienced, 21.7% reported unwilling sex; 17.5% had engaged in transactional sex; 57.8% had willing first sex, of whom 60.9% reported no condom use. Among those abstaining, female adolescents were less likely to contemplate condom use at first sex (p = 0.006). Our findings determine that young sexually active adolescents are likely engaging in unprotected sex and having unwilling sexual experiences. Socio-economic status, living situation and parental monitoring remain significant factors associated with sexual experience among young adolescents. In this context, early adolescence is an opportunity to provide age- and developmentally appropriate education about safer sex practices.Trial registration: ClinicalTrials.gov identifier: NCT04437667.

Understanding ART Adherence among Adolescent Girls and Young Women in Western Kenya: A Cross-Sectional Study of Barriers and Facilitators.

BACKGROUND: HIV remains a leading cause of death for adolescent girls and young women (AGYW) in sub-Saharan Africa. This population has a high incidence of HIV and other comorbidities, such as experiencing violence, and low antiretroviral therapy (ART) adherence. To reach global HIV goals, data are needed on the specific adherence barriers for AGYW living with HIV, so interventions can be targeted effectively. METHODS: Cross-sectional data were collected at urban and rural health facilities in and around Kisumu County, western Kenya, from January to June 2022, from AGYW 15-24 years of age who were living with HIV. Surveys included questions on intimate partner violence, mental health issues, food security, and orphanhood. Adherence was categorized using viral load testing where available and the Center for Adherence Support Evaluation (CASE) adherence index otherwise. Logistic regression was used to assess associations between potential explanatory variables and adherence. FINDINGS: In total, 309 AGYW participated. AGYW with experiences of emotional violence (Odds Ratio [OR] = 1.94, 95% Confidence Interval [CI] = 1.03-3.66), moderate or severe depression (OR = 3.19, 95% CI = 1.47-6.94), and/or substance use (OR = 2.71, 95% CI = 1.24-5.92) had significantly higher odds of poor adherence when compared to AGYW without these respective experiences. Physical and sexual violence, food insecurity, and orphanhood were not associated with poor adherence in this cohort. INTERPRETATION: Elucidating the risk factors associated with poor adherence among AGYW living with HIV allows us to identify potential targets for future interventions to improve ART adherence and HIV care outcomes. Mental health and violence prevention interventions, including combination interventions, may prove to be promising approaches.

The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19.

BACKGROUND: Adolescents contribute slightly less than one-third of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation and retention of the study participants in ongoing research. OBJECTIVE: The objective of our protocol is to determine (1) if Tumaini delays sexual debut and increases condom use at first sex and (2) whether it influences behavioral mediators of early and unprotected sex. METHODS: Participants were recruited from Kisumu County in Western Kenya. This study is a 2-arm, individual-randomized controlled trial that enrolled 1004 adolescents aged between 12 years and 15 years. The intervention arm participants are playing Tumaini, while the control arm is provided with Brainilis, a commercially available control game. The study period will last 45 months. At baseline, participants in both arms completed a baseline survey and biological testing for HIV and herpes simplex virus, type 2 (HSV-2); participants will have annual game play periods in years 1-3. They will also complete a total of 12 follow-up surveys. At endline, repeat biological testing will be conducted. Protocol adaptations were necessitated by the COVID-19 pandemic and implemented in accordance with local public health guidelines. RESULTS: Participants were enrolled between October 2020 and November 2020. We plan to complete study procedures in September 2024. The enrolled participant sample was 50.1% (499/996) female and had a mean age of 14.0 (SD 0.6) years. CONCLUSIONS: This ongoing research demonstrates that, with appropriate revisions to planned protocol activities guided by the need to maintain study integrity, protect both study participants and staff, and adhere to institutional review board and local health authority guidelines, human subject research is possible in the context of a global pandemic. If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to adolescents on safer sex, HIV prevention, and effective life skills on a highly scalable, low-cost, and culturally adaptable platform. TRIAL REGISTRATION: ClinicalTrials.gov NCT04437667; https://clinicaltrials.gov/ct2/show/NCT04437667. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35117.

A Smartphone Game to Prevent HIV Among Young Africans (Tumaini): Assessing Intervention and Study Acceptability Among Adolescents and Their Parents in a Randomized Controlled Trial.

BACKGROUND: Young people aged 15 to 24 years account for one-third of new adult HIV infections. Controlling the HIV epidemic requires effective interventions targeted toward young people and their needs. Smartphone games offer a promising avenue for reaching this population with evidence-based HIV prevention interventions. It is crucial to the effectiveness of these interventions that they be acceptable and intrinsically motivating to adolescents as well as acceptable to their parents. OBJECTIVE: Tumaini is a narrative-based smartphone game designed to help prevent HIV among young Africans aged 11 to 14 years by delaying first sex and increasing condom use at first sex. Following a 16-day feasibility study of Tumaini, we assessed the acceptability (1) of the intervention, where acceptability was operationalized as appeal, relevance, value, usability, and understandability, and (2) of this study and a planned future randomized controlled efficacy trial. METHODS: During the randomized feasibility study (n=60) of Tumaini in western Kenya in spring 2017, 30 participants used the intervention on a study-provided smartphone. The app automatically logged participant interaction with the game in time-stamped log files. All 30 participants completed an Audio Computer-Assisted Self-Interview-based game experience survey, and 27 took part in 4 focus group discussions (FGDs) about the game's appeal, relevance, value, usability, and understandability. Their parents (n=22) also participated in 4 FGDs about the acceptability of the intervention, of this study, and of a planned efficacy trial. Survey data were analyzed using SAS software (SAS Institute Inc); FGD transcripts were coded and analyzed in MAXQDA 12 (Verbi GmbH); and gameplay log files were analyzed using Microsoft Excel. RESULTS: Adolescent participants' survey responses indicated that Tumaini scored well with players on all indicators of acceptability (appeal, relevance, value, usability, and understandability). Focus group analyses aligned with these findings and emphasized a high degree of player engagement with the game, which was supported by log file analysis. Adolescent participants were eager for additional content, and parents were receptive to a longer study involving biomarkers, based on their positive experiences with this study. There is scope to improve communication with parents about their role in the intervention. As the game was tested in beta version, there is also scope to fine-tune some of the game mechanics to increase usability. CONCLUSIONS: This study shows the strong acceptability of an interactive smartphone-based game both to adolescents and their parents in western Kenya and that of the study methods used to pilot-test the intervention. It also suggests that longitudinal efficacy studies of this type of intervention, including those using biomarkers, have the potential to be acceptable among parents. TRIAL REGISTRATION: ClinicalTrials.gov NCT03054051; https://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/70U2gCNtW).

A Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Pilot Study of a Mobile Intervention.

BACKGROUND: Young people aged under 25 years make up an increasing proportion of the population in emerging economies such as Kenya, where half of new adult HIV infections are among 15- to 24-year olds. Interventions targeting this age group have the potential to avert HIV infections among an increasingly large at-risk population. Interactive communication technologies offer a promising platform for reaching young people in engaging ways. OBJECTIVE: Tumaini is a narrative-based smartphone game designed to help young Africans protect themselves from HIV. The objective of this study was to pilot test the game, focusing on the data needed to inform a future randomized controlled efficacy trial, including assessments of study feasibility and safety. METHODS: The study took place in Kisumu Town, western Kenya, in spring 2017. The game-based intervention was pilot tested for 16 days with a sample of 60 preadolescents aged 11 to 14 years. Participant recruitment was initiated through schools. Participants were randomly assigned to the control or intervention arms of the study. One parent for each of the intervention arm participants was also recruited (n=30). The intervention arm participants were provided with smartphones on which Tumaini was loaded so that they could play the game at home. Youth completed behavioral surveys at baseline, posttest, and 6-week follow-up. The intervention arm participants provided quantitative feedback on their experience of the game-based intervention at posttest. They and their parents further participated in postintervention focus group discussions. Feasibility-related study metrics were collected on recruitment, enrollment, attrition, safety of participants, and return of phones. RESULTS: Recruitment and enrollment of the 60 preadolescents and parents were successfully completed within 18 days. No participants were lost to follow-up: all youth completed all 3 waves of the survey and 27 intervention arm youth and 22 parents and caregivers participated in the focus groups. No safety concerns were reported. All phones were returned after the intervention period; none were damaged or lost. All intervention arm participants initiated gameplay, recording a mean exposure time just under 27 hours. CONCLUSIONS: Findings indicate that it is feasible and safe to test a smartphone-based HIV prevention intervention for very young adolescents in urban and peri-urban sub-Saharan Africa by initiating recruitment in schools and temporarily providing youth participants with smartphones on which the game is loaded. A randomized controlled trial powered to assess the efficacy of the game-based intervention is being designed to be carried out in the same geographic area as the pilot, using similar methods. TRIAL REGISTRATION: ClinicalTrials.gov NCT03054051; https://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/6wjwpX8Bg.). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11209.

Adverse fetal and infant outcomes among HIV-infected women who received either nonnucleoside reverse transcriptase inhibitor-based or protease inhibitor-based antiretroviral therapy for prevention of mother-to-child transmission.

BACKGROUND: For HIV-infected pregnant and breastfeeding women, antiretroviral therapy (ART) is known to reduce the mother's risk of passing the infection to her child. However, concerns remain about possible associations between various components of different ART regimens and adverse fetal and infant outcomes. As part of a clinical trial in western Kenya for the prevention of mother-to-child transmission (PMTCT) of HIV, pregnant women received one of two different ART regimens. METHODS: The original PMTCT study conducted in Kenya enrolled 522 HIV-infected, ART-naive pregnant women. These women were assigned to receive an ART regimen that included either nevirapine, a nonnucleoside reverse transcriptase inhibitor (NNRTI), or nelfinavir, a protease inhibitor. This substudy involves 384 women from the original study who had baseline CD4 cell counts at least 250 cells/µl, and compares the risks of adverse fetal and infant outcomes between the two ART regimens. RESULTS: There were 386 live births (including multiples) and 7 (1.8%) stillbirths. Among live births, there were 67 preterm deliveries, 37 low-birth weight infants, and 14 infant deaths by 6 months. There were no statistically significant differences between the two ART regimens for any of the reported adverse outcomes. CONCLUSION: Although these data do not show significant differences between the NNRTI-based or protease inhibitor-based regimens in serious adverse fetal and infant outcomes, more studies need to be done and careful vigilance is needed to ensure infant safety.

Correlation of Adherence by Pill Count, Self-report, MEMS and Plasma Drug Levels to Treatment Response Among Women Receiving ARV Therapy for PMTCT in Kenya.

Success of antiretroviral therapy depends on adherence to effective treatment. We evaluated four adherence methods and their correlation with immunological and virologic response among women receiving PMTCT. Univariable and multivariable analyses were used to assess how adherence by pill count (n = 463), self-report (n = 463), MEMS (n = 129) and plasma drug level (n = 89) was associated with viral load suppression within a 6 months period. Longitudinal analysis was performed to determine the correlation of CD4 cell count with each measure of adherence. For all measures of adherence, sustained viral suppression was less likely for participants in the lowest category of adherence. Although CD4 cell count increased substantially over time, there was no significant association with adherence by the methods. Multiple strategies can be used successfully to monitor treatment adherence. Persons with ≥95% adherence by any method used in this study were more likely to have a favorable treatment outcome.

Effect of point-of-care CD4 cell count results on linkage to care and antiretroviral initiation during a home-based HIV testing campaign: a non-blinded, cluster-randomised trial.

BACKGROUND: HIV disease staging with referral laboratory-based CD4 cell count testing is a key barrier to the initiation of antiretroviral treatment (ART). Point-of-care CD4 cell counts can improve linkage to HIV care among people living with HIV, but its effect has not been assessed with a randomised controlled trial in the context of home-based HIV counselling and testing (HBCT). METHODS: We did a two-arm, cluster-randomised, controlled efficacy trial in two districts of western Kenya with ongoing HBCT. Housing compounds were randomly assigned (1:1) to point-of-care CD4 cell counts (366 compounds with 417 participants) or standard-of-care (318 compounds with 353 participants) CD4 cell counts done at one of three referral laboratories serving the study catchment area. In each compound, we enrolled people with HIV not engaged in care in the previous 6 months. All participants received post-test counselling and referral for HIV care. Point-of-care test participants received additional counselling on the result, including ART eligibility if CD4 was less than 350 cells per µL, the cutoff in Kenyan guidelines. Participants were interviewed 6 months after enrolment to ascertain whether they sought HIV care, verified through chart reviews at 23 local clinics. The prevalence of loss to follow-up at 6 months (LTFU) was listed as the main outcome in the study protocol. We analysed linkage to care at 6 months (defined as 1-LTFU) as the primary outcome. All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT02515149. FINDINGS: We enrolled 770 participants between July 1, 2013, and Feb 28, 2014. 692 (90%) had verified linkage to care status and 78 (10%) were lost to follow-up. Of 371 participants in the point-of-care group, 215 (58%) had linked to care within 6 months versus 108 (34%) of 321 in the standard-of-care group (Cox proportional multivariable hazard ratio [HR] 2·14, 95% CI 1·67-2·74; log rank p<0·0001). INTERPRETATION: Point-of-care CD4 cell counts in a resource-limited HBCT setting doubled linkage to care and thereby improved ART initiation. Given the substantial economic and logistic hindrances to providing ART for all people with HIV in resource-limited settings in the near term, point of care CD4 cell counts might have a role in prioritising care and improving linkage to care. FUNDING: US Centers for Disease Control and Prevention.

Prevalence, incidence and correlates of HSV-2 infection in an HIV incidence adolescent and adult cohort study in western Kenya.

BACKGROUND: Herpes simplex virus type 2 (HSV-2) infections are associated with increased risk of HIV transmission. We determined HSV-2 prevalence, incidence and associated risk factors, incidence among persons with indeterminate results, and prevalence of HSV-2/HIV co-infection among young adults (18-34 years) and adolescents (16-17 years) enrolled in an HIV incidence cohort study in western Kenya. METHODS: Participants (n = 1106; 846 adults) were screened and those HIV-1 negative were enrolled and followed-up quarterly for one year. HSV-2 was assessed using the Kalon enzyme immunoassay. HSV-2 incidence was calculated separately among HSV-2 seronegative participants and those indeterminate at baseline. Logistic regression was used to estimate the odds of HSV-2 infection and Poisson regression was used to assess HSV-2 incidence and associated factors. RESULTS: Overall, HSV-2 prevalence was 26.6% [95% confidence interval (CI): 23.9-29.4] and was higher in adults (31.5% [95% CI: 28.3-34.9]) than adolescents (10.7% [95% CI: 7.1-15.3]). Factors associated with prevalent HSV-2 included female gender, increasing age, HIV infection, history of sexually transmitted infection, low level of education, multiple sexual partners, and being married, divorced, separated or widowed. Overall HSV-2 incidence was 4.0 per 100 person-years (/100PY) 95% CI: 2.7-6.1 and was higher in adults (4.5/100PY) and females (5.1/100PY). In multivariable analysis only marital status was associated with HSV-2 incidence. Among 45 participants with indeterminate HSV-2 results at baseline, 22 seroconverted, resulting in an incidence rate of 53.2 /100PY [95% CI: 35.1-80.9]. Inclusion of indeterminate results almost doubled the overall incidence rate to 7.8 /100 PY [95% CI: 5.9-10.5]. Prevalence of HIV/HSV-2 co-infection was higher in female adults than female adolescents (17.1 [95% CI: 13.6-21.0] versus 3.4 [95% CI: 1.1-7.8]). CONCLUSION: The high incidence rate among persons with indeterminate results underscores the public health concerns for HSV-2 spread and underreporting of the HSV-2 burden. Careful consideration is needed when interpreting HSV-2 serology results in these settings.

Investigation of HIV Incidence Rates in a High-Risk, High-Prevalence Kenyan Population: Potential Lessons for Intervention Trials and Programmatic Strategies.

Cost-effective HIV prevention programs should target persons at high risk of HIV acquisition. We conducted an observational HIV incidence cohort study in Kisumu, Kenya, where HIV prevalence is triple that of the national rate. We used referral and venue-sampling approaches to enroll HIV-negative persons for a 12-month observational cohort, August 2010 to September 2011, collected data using computer-assisted interviews, and performed HIV testing quarterly. Among 1292 eligible persons, 648 (50%) were excluded for HIV positivity and other reasons. Of the 644 enrollees, 52% were women who were significantly older than men (P<.01). In all, 7 persons seroconverted (incidence rate [IR] per 100 person-years=1.11; 95% confidence interval [CI] 0.45-2.30), 6 were women; 5 (IR=3.14; 95% CI 1.02-7.34) of whom were ≤25 years. Most new infections occurred in young women, an observation consistent with other findings in sub-Saharan Africa that women aged ≤25 years are an important population for HIV intervention trials in Africa.

Determinants and Experiences of Repeat Pregnancy among HIV-Positive Kenyan Women--A Mixed-Methods Analysis.

OBJECTIVE: To identify factors associated with repeat pregnancy subsequent to an index pregnancy among women living with HIV (WLWH) in western Kenya who were enrolled in a 24-month phase-II clinical trial of triple-ART prophylaxis for prevention of mother-to-child transmission, and to contextualize social and cultural influences on WLWH's reproductive decision making. METHODS: A mixed-methods approach was used to examine repeat pregnancy within a 24 month period after birth. Counselor-administered questionnaires were collected from 500 WLWH. Forty women (22 with a repeat pregnancy; 18 with no repeat pregnancy) were purposively selected for a qualitative interview (QI). Simple and multiple logistic regression analyses were performed for quantitative data. Thematic coding and saliency analysis were undertaken for qualitative data. RESULTS: Eighty-eight (17.6%) women had a repeat pregnancy. Median maternal age was 23 years (range 15-43 years) and median gestational age at enrollment was 34 weeks. In multiple logistic regression analyses, living in the same compound with a husband (adjusted odds ratio (AOR): 2.33; 95% confidence interval (CI): 1.14, 4.75) was associated with increased odds of repeat pregnancy (p ≤ 0.05). Being in the 30-43 age group (AOR: 0.25; 95% CI: 0.07, 0.87), having talked to a partner about family planning (FP) use (AOR: 0.53; 95% CI: 0.29, 0.98), and prior usage of FP (AOR: 0.45; 95% CI: 0.25, 0.82) were associated with a decrease in odds of repeat pregnancy. QI findings centered on concerns about modern contraception methods (side effects and views that they 'ruined the womb') and a desire to have the right number of children. Religious leaders, family, and the broader community were viewed as reinforcing cultural expectations for married women to have children. Repeat pregnancy was commonly attributed to contraception failure or to lack of knowledge about post-delivery fertility. CONCLUSIONS: In addition to cultural context, reproductive health programs for WLWH may need to address issues related to living circumstances and the possibility that reproductive-decision making may extend beyond the woman and her partner.

Correlates of prevalent HIV infection among adults and adolescents in the Kisumu incidence cohort study, Kisumu, Kenya.

We estimated HIV prevalence and identified correlates of HIV infection among 1106 men and women aged 16-34 years residing in Kisumu, Kenya. Demographic, sexual, and other behavioural data were collected using audio computer-assisted self-interview in conjunction with a medical examination, real-time parallel rapid HIV testing, and laboratory testing for pregnancy, gonorrhoea, chlamydia, syphilis, and herpes simplex virus type 2. Multivariate logistic regression was used to identify variables associated with prevalent HIV infection by gender. Overall HIV prevalence was 12.1%. HIV prevalence among women (17.1%) was approximately two-and-one-half times the prevalence among men (6.6%). Odds of HIV infection in men increased with age (aOR associated with one-year increase in age = 1.21, CI = 1.07-1.35) and were greater among those who were uncircumcised (aOR = 4.42, CI = 1.41-13.89) and those who had an herpes simplex virus type 2-positive (aOR = 3.13, CI = 1.12-8.73) test result. Odds of prevalent HIV infection among women also increased with age (aOR associated with one-year increase in age = 1.16, CI = 1.04-1.29). Women who tested herpes simplex virus type 2 positive had more than three times the odds (aOR = 3.85, CI = 1.38-10.46) of prevalent HIV infection compared with those who tested herpes simplex virus type 2 negative. Tailored sexual health interventions and programs may help mitigate HIV age and gender disparities.

Neutropenia in HIV-Infected Kenyan Women Receiving Triple Antiretroviral Prophylaxis to Prevent Mother-to-Child HIV Transmission Is Not Associated with Serious Clinical Sequelae.

BACKGROUND: Absolute neutrophil counts (ANCs) are lower in East African adults. To assess the impact of lower ANCs, we reviewed data from HIV-infected Kenyan women receiving antiretroviral therapy antepartum and postpartum. METHODS: The Kisumu Breastfeeding Study (KiBS) participants received an antiretroviral regimen from 34 weeks' gestation through 6 months postpartum. Measured ANCs and subsequent illnesses were reviewed. Adverse events (AEs) potentially attributable to neutropenia were identified, and ANCs were graded using the 2004 Division of AIDS table for Grading the Severity of AEs. RESULTS: Among 478 women with ≥1 postpartum ANC measured, 298 (62.1%) women met criteria for an AE (<1.3 × 10(9) cells/L). Of those, 38 (12.5%) women experienced a nonlife-threatening illness potentially attributable to neutropenia. CONCLUSION: More than half of KiBS women met criteria for neutropenia. The mild clinical experience of most participants with low ANCs supports that these values might be typical for this population and may not result in adverse clinical sequelae.

Correlates of prevalent sexually transmitted infections among participants screened for an HIV incidence cohort study in Kisumu, Kenya.

We determined the prevalence of four sexually transmitted infections and the demographic and behavioural correlates associated with having one or more sexually transmitted infections among participants in an HIV incidence cohort study in Kisumu, western Kenya. Participants were enrolled from a convenience sample and underwent aetiologic sexually transmitted infection investigation. Demographic and behavioural information were collected and basic clinical evaluation performed. Multiple regression analysis was done to determine variables associated with having one or more sexually transmitted infections. We screened 846, 18- to 34-year-olds. One-third had at least one sexually transmitted infection with specific prevalence being: syphilis, 1.6%; gonorrhoea, 2.4%; herpes simplex virus type-2, 29.1%; chlamydia, 2.8%; and HIV, 14.8%. Odds of having any sexually transmitted infection were higher among participants who were women, were aged 20-24 or 30-34 years compared to 18-19 years, had secondary or lower education compared to tertiary education, were divorced, widowed or separated compared to singles, reported having unprotected sex compared to those who did not, reported previous sexually transmitted infection treatment, and tested HIV-positive. Multiple strategies are needed to address the overall high prevalence of sexually transmitted infections as well as the gender disparity found in this Kenyan population. Structural interventions may be beneficial in addressing educational and socio-economic barriers, and increasing the uptake of health-promoting practices.

Evaluation of syndromic management of sexually transmitted infections within the Kisumu Incidence Cohort Study.

While laboratory aetiological diagnosis is considered the gold standard for diagnosis and management of sexually transmitted infections (STIs), syndromic management has been presented as a simplified and affordable approach for STI management in limited resource settings. STI signs and symptoms were collected using staff-administered computer-assisted personal interview and audio computer-assisted self-interview. Participants underwent a medical examination and laboratory testing for common STIs. The performance of syndromic management was assessed on the agreement between interviewing methods as well as accurate diagnosis. We screened 846 participants, of whom 88 (10.4%) received syndromic STI diagnosis while 272 (32.2%) received an aetiological diagnosis. Agreement between syndromic and aetiological diagnoses was very poor (overall kappa = 0.09). The most prevalent STI was herpes simplex virus type 2 and the percentage of persons with any STI was higher among women (48.6%) than men (15.6%, p < 0.0001). Agreement between audio computer-assisted self-interview and computer-assisted personal interview interviewing methods for syndromic diagnosis of STIs ranged from poor to good. Our findings suggest that syndromic management of STIs is not a sufficient tool for STI diagnosis in this setting; development and improvement of STI diagnostic capabilities through laboratory confirmation is needed in resource-limited settings.

Rash, hepatotoxicity and hyperbilirubinemia among Kenyan infants born to HIV-infected women receiving triple-antiretroviral drugs for the prevention of mother-to-child HIV transmission.

We compared adverse events among breast-feeding neonates born to Kenyan mothers receiving triple-antiretroviral therapy, including either nevirapine or nelfinavir. Nevirapine-exposed infants had an absolute increase in the risk of rash but no significant risk differences for hepatotoxicity or high-risk hyperbilirubinemia compared with nelfinavir-exposed infants. From an infant-safety perspective, nevirapine-based regimens given during pregnancy and breast-feeding are viable options where alternatives to breast milk are not safe, affordable or feasible.

Nevirapine-associated hepatotoxicity and rash among HIV-infected pregnant women in Kenya.

BACKGROUND: Few studies have evaluated the risk of nevirapine (NVP)-associated hepatotoxicity among HIV-infected pregnant women with a CD4 count ≥250 cells/mm(3). METHODS: We enrolled HIV-infected pregnant Kenyan women who initiated triple antiretroviral therapy (ART) at 34 weeks gestation. We compared the rates of severe hepatotoxicity (grades 3-4 hepatotoxicity) and rash-associated hepatotoxicity (rash with ≥grade 2 hepatotoxicity) with NVP and nelfinavir (NFV), respectively. RESULTS: We initiated triple ART in 522 pregnant women; severe hepatotoxicity and rash-associated hepatotoxicity occurred in 14 (3%) and 9 (2%) women, respectively. Women who initiated NVP had higher rates of severe hepatotoxicity (5% vs 1%; P = .03) and rash-associated hepatotoxicity (4% vs 0%; P = .003) when compared with NFV. Among women who initiated NVP (n = 254), a baseline CD4 count ≥250 cells/mm(3) was not associated with severe hepatotoxicity (5% vs 3%; P = .52) or rash-associated hepatotoxicity (4% vs 3%; P = .69). CONCLUSION: Nevirapine use but not CD4 count ≥250 cells/mm(3) was associated with hepatotoxicity.

Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding--the Kisumu Breastfeeding Study, Kenya: a clinical trial.

BACKGROUND: Effective strategies are needed for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. The Kisumu Breastfeeding Study was a single-arm open label trial conducted between July 2003 and February 2009. The overall aim was to investigate whether a maternal triple-antiretroviral regimen that was designed to maximally suppress viral load in late pregnancy and the first 6 mo of lactation was a safe, well-tolerated, and effective PMTCT intervention. METHODS AND FINDINGS: HIV-infected pregnant women took zidovudine, lamivudine, and either nevirapine or nelfinavir from 34-36 weeks' gestation to 6 mo post partum. Infants received single-dose nevirapine at birth. Women were advised to breastfeed exclusively and wean rapidly just before 6 mo. Using Kaplan-Meier methods we estimated HIV-transmission and death rates from delivery to 24 mo. We compared HIV-transmission rates among subgroups defined by maternal risk factors, including baseline CD4 cell count and viral load. Among 487 live-born, singleton, or first-born infants, cumulative HIV-transmission rates at birth, 6 weeks, and 6, 12, and 24 mo were 2.5%, 4.2%, 5.0%, 5.7%, and 7.0%, respectively. The 24-mo HIV-transmission rates stratified by baseline maternal CD4 cell count <500 and ≥500 cells/mm(3) were 8.4% (95% confidence interval [CI] 5.8%-12.0%) and 4.1% (1.8%-8.8%), respectively (p = 0.06); the corresponding rates stratified by baseline maternal viral load <10,000 and ≥10,000 copies/ml were 3.0% (1.1%-7.8%) and 8.7% (6.1%-12.3%), respectively (p = 0.01). None of the 12 maternal and 51 infant deaths (including two second-born infants) were attributed to antiretrovirals. The cumulative HIV-transmission or death rate at 24 mo was 15.7% (95% CI 12.7%-19.4%). CONCLUSIONS: This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for PMTCT is safe and feasible in a resource-limited setting. These findings are consistent with those from other trials using maternal triple-antiretroviral regimens during breastfeeding in comparable settings.

Effect of a point-of-use water treatment and safe water storage intervention on diarrhea in infants of HIV-infected mothers.

To reduce mother-to-child transmission of human immunodeficiency virus (HIV) in resource-poor settings, the World Health Organization recommends exclusive breast-feeding for 6 months, followed by rapid weaning if replacement feeding is affordable, feasible, available, safe, and sustainable. In the Kisumu Breastfeeding Study (trial registration: Clinicaltrials.gov identifier NCT00146380), infants of HIV-infected mothers who received antiretroviral therapy experienced high rates of diarrhea at weaning. To address this problem, mothers in the Kisumu Breastfeeding Study were given safe water storage vessels, hygiene education, and bleach for household water treatment. We compared the incidence of diarrhea in infants enrolled before (cohort A) and after (cohort B) implementation of the intervention. Cohort B infants experienced less diarrhea than cohort A infants, before and after weaning (P < .001 and P = .047, respectively); however, during the weaning period, there were no differences in the frequency of diarrhea between cohorts (P = 0.89). Testing of stored water in cohort B homes indicated high adherence (monthly range, 80%-95%) to recommended chlorination practices. Among infants who were weaned early, provision of safe water may be insufficient to prevent weaning-associated diarrhea.