Application of a Social Vulnerability Index and Its Associations with Physical Frailty and Disability in a Cross-sectional Study of Older Kenyan Women Living with and without HIV.

Background: Social vulnerability reflects deficits in social resources that may disproportionally impact older women with HIV (WWH) in Africa.

Objective: To examine the relationship between scores on an adapted Social Vulnerability Index (SVI) and measures of physical frailty and disability.

Design: Cross-sectional study.

Impact of point-of-care HIV viral load and targeted drug resistance mutation testing on viral suppression among Kenyan pregnant and postpartum women: results from a prospective cohort study (Opt4Mamas).

Introduction: Lack of viral suppression (VS) among pregnant and breastfeeding women living with HIV poses challenges for maternal and infant health, and viral load (VL) monitoring via centralized laboratory systems faces many barriers. We aimed to determine the impact of point-of-care (POC) VL and targeted drug resistance mutation (DRM) testing in improving VS among pregnant and postpartum women on antiretroviral therapy.

Methods: We conducted a pre/post-intervention prospective cohort study among 820 pregnant women accessing HIV care at five public-sector facilities in western Kenya from 2019 to 2022.

Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls in western Kenya: a cluster randomised controlled trial.

Background: High rates of sexual and reproductive health (SRH) harms and interrupted schooling are global challenges for adolescent girls, requiring effective interventions. We assessed the impact of menstrual cups (MCs) or cash transfers conditioned on school attendance (CCTs), or both, on SRH and schooling outcomes in western Kenya.

Methods: In this cluster-randomised Cups or Cash for Girls (CCG) trial, adolescent girls in Forms two and three at 96 secondary schools in Siaya County (western Kenya) were randomised to receive either CCT, MC, combined CCT and MC, or control (1:1:1:1) for an average of 30 months.

A prospective preconception cohort study of the association between Mycoplasma genitalium and fecundability in Kenyan women trying to conceive.

Study Question: Is Mycoplasma genitalium-infection associated with reduced fecundability?

Summary Answer: Preconception M. genitalium-infection was associated with 27% lower fecundability though confidence intervals were wide, and the association between M. genitalium and fecundability may be dependent on concurrent bacterial vaginosis (BV).

"I feel drug resistance testing allowed us to make an informed decision": qualitative insights on the role of HIV drug resistance mutation testing among children and pregnant women living with HIV in western Kenya.

Background: Pregnant women and children living with HIV in Kenya achieve viral suppression (VS) at lower rates than other adults. While many factors contribute to these low rates, the acquisition and development of HIV drug resistance mutations (DRMs) are a contributing factor. Recognizing the significance of DRMs in treatment decisions, resource-limited settings are scaling up national DRM testing programs.

"After viral load testing, I get my results so I get to know which path my life is taking me": qualitative insights on routine centralized and point-of-care viral load testing in western Kenya from the Opt4Kids and Opt4Mamas studies.

Background: Viral suppression (VS) is a marker of effective HIV therapy, and viral load (VL) testing is critical for treatment monitoring, especially in high-risk groups such as children and pregnant/postpartum women. Although routine VL testing, via centralized laboratory networks, was implemented in Kenya starting in 2014, optimization and sustainable scale up of VL testing are still needed.

Methods: We conducted a mixed methods study to evaluate the impact of higher frequency, point-of-care (POC) VL testing in optimizing VS among children and pregnant/postpartum women on antiretroviral treatment (ART) in five HIV treatment facilities in western Kenya in the Opt4Kids and Opt4Mamas studies.

Prevalence and correlates of periodontitis among Kenyan women planning to conceive.

Background: Periodontitis has been associated with adverse pregnancy outcomes. Little is known about the burden and risk factors for periodontitis among reproductive age women in sub-Saharan Africa. This analysis aimed to determine the prevalence and correlates of periodontitis among Kenyan women planning to conceive.

Adaptation of a social vulnerability index for measuring social frailty among East African women.

Background: The number of older women living with HIV in Africa is growing, and their health outcomes may be adversely impacted by social frailty, which reflects deficits in social resources that accumulate over the lifespan. Our objective was to adapt a Social Vulnerability Index (SVI) originally developed in Canada for use in a study of older women living with or without HIV infection in Mombasa, Kenya.

Methods: We adapted the SVI using a five-step process: formative qualitative work, translation into Kiswahili, a Delphi procedure, exploration of potential SVI items in qualitative work, and a rating and ranking exercise.

Vaginal washing behaviour and fecundability among Kenyan women in a prospective preconception cohort.

Background: Intravaginal washing, practised by a significant proportion of women globally, is associated with acquisition of human immunodeficiency virus (HIV), sexually transmitted infections and bacterial vaginosis (BV). A single prior study among women in the United States found that vaginal washing was associated with lower fecundability.

Objective: To examine the association between vaginal washing and fecundability among Kenyan women.

Evaluation of the Performance of OraQuick Rapid HIV-1/2 Test Among Decedents in Kisumu, Kenya.

Background: Estimating cause-related mortality among the dead is not common, yet for clinical and public health purposes, a lot can be learnt from the dead. HIV/AIDS accounted for the third most frequent cause of deaths in Kenya; 39.7 deaths per 100,000 population in 2019.

Factors associated with the prevalence of HIV, HSV-2, pregnancy, and reported sexual activity among adolescent girls in rural western Kenya: A cross-sectional analysis of baseline data in a cluster randomized controlled trial.

Background: Adolescence is a sensitive time for girls' sexual and reproductive health (SRH), as biological changes occur concurrently with heightening pressures for sexual activity. In western Kenya, adolescent girls are vulnerable to acquiring sexually transmitted infections (STIs), such as HIV and herpes simplex virus type 2 (HSV-2), and to becoming pregnant prior to reaching adulthood. This study examines associations between individual, household, and partner-related risk factors and the prevalence of sex, adolescent pregnancy, HIV, and HSV-2.

High HIV prevalence among decedents received by two high-volume mortuaries in Kisumu, western Kenya, 2019.

Background: Accurate data on HIV-related mortality are necessary to evaluate the impact of HIV interventions. In low- and middle-income countries (LMIC), mortality data obtained through civil registration are often of poor quality. Though not commonly conducted, mortuary surveillance is a potential complementary source of data on HIV-associated mortality.

Nugent Score, Amsel's Criteria, and a Point-of-Care Rapid Test for Diagnosis of Bacterial Vaginosis: Performance in a Cohort of Kenyan Women.

There are minimal data on the BVBlue test for diagnosis of bacterial vaginosis (BV) in Africa. Among 701 Kenyan women, compared with Nugent score ≥7, the BVBlue test had moderate sensitivity (81.9%; 95% confidence interval, 76.

Optimizing viral load suppression in Kenyan children on antiretroviral therapy (Opt4Kids).

Background: As many as 40% of the 1 million children living with HIV (CLHIV) receiving antiretroviral treatment (ART) in resource limited settings have not achieved viral suppression (VS). Kenya has a large burden of pediatric HIV with nearly 140,000 CLHIV. Feasible, scalable, and cost-effective approaches to ensure VS in CLHIV are urgently needed.

Menstrual cups and cash transfer to reduce sexual and reproductive harm and school dropout in adolescent schoolgirls: study protocol of a cluster-randomised controlled trial in western Kenya.

Background: Adolescent girls in sub-Saharan Africa are disproportionally vulnerable to sexual and reproductive health (SRH) harms. In western Kenya, where unprotected transactional sex is common, young females face higher rates of school dropout, often due to pregnancy, and sexually transmitted infections (STIs), including HIV. Staying in school has shown to protect girls against early marriage, teen pregnancy, and HIV infection.

Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis.

Background: Access to point-of-care HIV testing shortens turn-around times, time to diagnosis and reduces loss to follow-up hence minimizing barriers to early linkage to care and treatment among HIV infected infants. Currently samples for early infant HIV diagnosis are sent to centralized testing facilities which are few and located only at specific regions in Kenya. However, there are Point of Care (POC) early infant diagnosis [EID] technologies elsewhere such as SAMBA and ALERE-Q that are yet to be evaluated in Kenya despite the urgent need for data to inform policy formulation regarding EID.

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.

Establishment of reference intervals during normal pregnancy through six months postpartum in western Kenya.

Background: Pregnancy is associated with changes in hematological and biochemistry values, yet there are no African reference intervals for clinical management of pregnant women. We sought to 1) develop laboratory reference intervals during pregnancy and up to 24 weeks postpartum and 2) determine the proportion of women in a previous clinical trial who would be misclassified as having out-of-range values using reference intervals from a United States (U.S.

Residual hormone levels in used contraceptive rings as a measurement of adherence to vaginal ring use.

Objective: This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials.

Study Design: Residual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice.

Results: Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice.

Evaluation of locally established reference intervals for hematology and biochemistry parameters in Western Kenya.

Background: Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities.

Methods: An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya.

Field evaluation of a broadly sensitive HIV-1 in-house genotyping assay for use with both plasma and dried blood spot specimens in a resource-limited country.

HIV-1 drug resistance (HIVDR) assays are important tools in clinical management of HIV-infected patients on antiretroviral therapy (ART) and surveillance of drug-resistant variants at population levels. The high cost associated with commercial assays hinders their use in resource-limited settings. We adopted and validated a low-cost in-house assay using 68 matched plasma and dried blood spot (DBS) samples with a median viral load (VL) of 58,187 copies/ml, ranging from 253 to 3,264,850 against the commercial assay ViroSeq.

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.