Detection of types of HPV among HIV-infected and HIV-uninfected Kenyan women undergoing cryotherapy or loop electrosurgical excision procedure

Objective: To assess the baseline types of HPV infection among HIV-positive and HIV-negative women in western Kenya undergoing cryotherapy or loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia. Methods: A prospective observational study was conducted of baseline HPV characteristics of women undergoing visual inspection with acetic acid (VIA) and cryotherapy or LEEP. After a positive VIA in HIV-positive and HIV-negative women, data on demographics, CD4 count, and use of antiretroviral therapy and a cervical swab were collected. HPV typing was performed using the Roche Linear Array. Results: Of 175 participants, 86 (49.1%) were HIV-positive and had a higher prevalence of low-risk HPV types (odds ratio [OR] 5.28, P=0.005) compared with HIV-negative women. The most common high-risk (HR)-HPV types in HIV-positive women were HPV 16 (13.9%) and HPV 18 (11.1%). HIV-positive women requiring LEEP were more likely to have HR-HPV types (OR 6.67, P=0.012) and to be infected with multiple HR-HPV types (OR 7.79, P=0.024) compared to those undergoing cryotherapy. Conclusion: HIV-positive women requiring LEEP versus cryotherapy had a higher prevalence of any HR-HPV type and multiple HR-HPV types. There were no such differences in HPV types identified among HIV-negative women

Microfinance, retention in care, and mortality among patients enrolled in HIV 2 Care in East Africa

Objective: To measure associations between participation in community-based microfinance groups, retention in HIV care, and death among people with HIV (PWH) in low-resource settings. Design and methods: We prospectively analyzed data from 3609 patients enrolled in an HIV care program in western Kenya. HIV patients who were eligible and chose to participate in a Group Integrated Savings for Health Empowerment (GISHE) microfinance group were matched 1 : 2 on age, sex, year of enrollment in HIV care, and location of initial HIV clinic visit to patients not participating in GISHE. Follow-up data were abstracted from medical records from January 2018 through February 2020. Logistic regression analysis examined associations between GISHE participation and two outcomes: retention in HIV care (i.e. >1 HIV care visit attended within 6 months prior to the end of follow-up) and death. Socioeconomic factors associated with HIV outcomes were included in adjusted models. Results: The study population was majority women (78.3%) with a median age of 37.4 years. Microfinance group participants were more likely to be retained in care relative to HIV patients not participating in a microfinance group [adjusted odds ratio (aOR) = 1.31, 95% confidence interval (CI) 1.01–1.71; P = 0.046]. Participation in group microfinance was associated with a reduced odds of death during the follow-up period (aOR = 0.57, 95% CI 0.28–1.09; P = 0.105). Conclusion: Participation in group-based microfinance appears to be associated with better HIV treatment outcomes. A randomized trial is needed to assess whether microfinance groups can improve clinical and socioeconomic outcomes among PWH in similar settings

Contraception use and HIV outcomes among women initiating dolutegravir-containing antiretroviral therapy in Kenya: a retrospective cohort study

Introduction: The rollout of dolutegravir (DTG) in low- and middle-income countries was disrupted by a potential association reported with periconceptional DTG exposure among women living with HIV (WLHIV) and infant neural tube defects. This prompted countries to issue interim guidance limiting DTG use among women of reproductive potential to those on effective contraception. Data to understand the potential impact of such guidance on WLHIV are limited. Methods: We conducted a retrospective cohort analysis of WLHIV 15-49 years initiating DTG-containing antiretroviral treatment (ART) in Kenya from 2017 to 2020. We determined baseline effective (oral, injectable or lactational amenorrhea) and very effective (implant, intrauterine device or female sterilization) contraception use among women who initiated DTG before (Group 1) or during (Group 2) the interim guideline period. We defined incident contraception use in each group as the number of contraceptive methods initiated ≤180 days post-guideline (Group 1) or post-DTG initiation (Group 2). We determined the proportions of all women who switched from DTG- to non-nucleoside reverse transcriptase inhibitor (NNRTI)- (efavirenz or nevirapine) containing ART ≤12 months post-DTG initiation, compared their viral suppression (<1000 copies/ml) and conducted multivariable logistic regression to determine factors associated with switching from DTG to NNRTI-containing ART. Results: Among 5155 WLHIV in the analysis (median age 43 years), 89% initiated DTG after transitioning from an NNRTI. Baseline effective and very effective contraception use, respectively, by the group were: Group 1 (12% and 13%) and Group 2 (41% and 35%). Incident contraception use in each group was <5%. Overall, 498 (10%) women switched from DTG to an NNRTI. Viral suppression among those remaining on DTG versus switched to NNRTI was 95% and 96%, respectively (p = 0.63). In multivariable analysis, incident effective and very effective contraception use was not associated with switching. Conclusions: Baseline, but not incident, effective contraception use was higher during the interim guideline period compared to before it, suggesting women already using effective contraception were preferentially selected to initiate DTG after the guideline was released. These findings reveal challenges in the implementation of policy which ties antiretroviral access to contraceptive use. Future guidance should capture nuances of contraception decision-making and support women's agency to make informed decisions

Cryotherapy and LEEP are effective treatment for CIN lesions in HIV+ and HIV- women in western Kenya

Objectives: Cervical cancer is the third most common cancer worldwide and the most common cancer among Kenyan women, with an age-standardized incidence rate of 33.8% in 2018. Cervical intraepithelial neoplasia (CIN) caused by human papillomavirus (HPV) in HIV+ women is over twice as likely to progress in severity compared to HIV- women. Conflicting reports exist as to the efficacy of cryotherapy or loop electrosurgical excision procedure (LEEP) as treatment for CIN among HIV+ women. This study assesses the results of cryotherapy or LEEP for CIN among HIV+ compared to HIV- women in Western Kenya. Methods: One-hundred and twenty HIV+ (60 cryotherapy, 60 LEEP) and 120 HIV- (60 cryotherapy and 60 LEEP) women were intended to be enrolled after a positive visual inspection with acetic acid (VIA). However, only 86 HIV+ (39 cryotherapy, 47 LEEP) and 89 HIV- (46 cryotherapy, 43 LEEP) who had follow-up of 24 months were included in this analysis. Women were eligible for cryotherapy if the lesion covered low grade intraepithelial lesion (LSIL) on Pap smear or ≥ CINI on histology, LEEP failure was defined as high grade intraepithelial lesion (HSIL) on Pap smear or ≥ CIN 2 after treatment. Chi square and Fishers’ exact tests were used to compare the proportions. Results: There was no statistically significant difference in treatment failure rates between HIV+ and HIV- patients (10.1% v 19.8% p =0.09). Among patients who underwent cryotherapy, there was no statistically significant difference in treatment failure between HIV+ and HIV- women (18% v 4.4%, p = 0.073). No statistically significant difference in treatment failure was observed among HIV+ and HIV- women who underwent LEEP (16.3% v 21.3%, p = 0.599). No statistically significant difference in treatment failure was observed between all patients in the LEEP arm compared to those in the cryotherapy arm (10.6% v 18.9% p =0.141). Seventy-four percent of HIV+ women were on antiretroviral therapy (ART) during the study, and 91% had been on ART during or prior to the study. Mean CD4 count among HIV+ women was 580. Conclusions: In our experience, cryotherapy and LEEP are effective treatment for HIV+ and HIV- women if done for appropriate CIN lesions in low-resource settings

LEEP more effective than cryotherapy as effective treatment for CIN lesions in women living with HIV and without HIV in western Kenya

Objectives: Cervical intraepithelial neoplasia (CIN) in women with HIV (WHIV) is over twice as likely to progress in severity than in women without HIV. This study assessed the results of cryotherapy or LEEP for CIN among WHIV compared to women without HIV in Western Kenya. Methods: A total of 120 WHIV (60 cryotherapies, 60 LEEP) and 120 women without HIV (60 cryotherapies and 60 LEEP) were intended to be enrolled after a positive visual inspection with acetic acid (VIA). However, only 86 WHIV (39 cryotherapies, 47 LEEP) and 89 women without HIV (46 cryotherapies, 43 LEEP) who had follow-ups within 24 months were included in this analysis. Women were eligible for cryotherapy if the lesion covered b75% of the transformation zone, did not extend into the endocervical canal, and was not N CIN 2 on histology. Women ineligible for cryotherapy underwent colposcopy/ biopsy, and those with confirmed CIN 2/3 underwent LEEP. Women had a follow-up every 6 months with VIA, Pap smear, or colposcopy/ biopsy. Cryotherapy failure was defined as N low-grade intraepithelial lesion (LSIL) on Pap smear or N CIN 1 on histology. LEEP failure was defined as a high-grade intraepithelial lesion (HSIL) on Pap smear or N CIN 2 by histology after treatment. χ2 and Fisher\u27s exact tests were used to compare the proportions. Results: There was a significant difference in treatment failure rates between WHIV and women without HIV (15.12% vs 5.62%, P = 0.04). The population average odds of treatment failure were higher in HIVpositive subjects compared to HIV-negative subjects (OR: 4.39, 95% CI: 1.23–15.64). There was a significant difference in treatment failure rates between WHIV compared to women without HIV who underwent cryotherapy (18.00% v 2.20%, P = 0.021). Among patients who underwent LEEP, no difference was observed in the treatment failure rates between WHIV and women without HIV (12.80% vs 9.30%, P = 0.74). There was no association between treatments and these covariates: married (OR: 3.55, 95% CI: 0.4–31.29), widowed (OR: 2.8, 95% CI: 0.19–40.97), secondary education (OR: 1.50, 95% CI: 0.42–5.39), college/university education (OR: 1.75, 95% CI: 0.25–12), unemployment (OR: 2.30, 95% CI: 0.39–13.18), age group 31–40 (OR: 0.91, 95% CI: 0.26–3.17) and aged 41+ (OR: 0.36, 95% CI: 0.08–1.74). For the patients in the LEEP arm of treatment, there was no association between these covariates and treatment failure: age at first sexual encounter (OR: 1.15, 95% CI: 0.91–1.45), condom use in the last 6 months (OR: 0.91, 95% CI: 0.56–1.49), HIV status (OR: 3.97, 95% CI: 0.66–23.96), self-employed (OR 0.63, 95% CI: 0.07–6.08), secondary education (OR 3.89, 95% CI: 0.42–30.54) and married (OR: 0.32, 95% CI: 0.01–7.87). Conclusions: In our experience, LEEP is a more effective treatment for WHIV compared to women without HIV for CIN in Western Keny

Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya

Background: The Harambee study is a cluster randomized trial in Western Kenya that tests the effect, mechanisms, and cost-effectiveness of integrating community-based HIV and non-communicable disease care within microfinance groups on chronic disease treatment outcomes. This paper documents the stages of our feasibility study conducted in preparation for the Harambee trial, which include (1) characterizing the target population and gauging recruitment capacity, (2) determining community acceptability of the integrated intervention and study procedures, and (3) identifying key implementation considerations prior to study start. Methods: Feasibility research took place between November 2019 and February 2020 in Western Kenya. Mixed methods data collection included surveys administered to 115 leaders of 105 community-based microfinance groups, 7 in-person meetings and two workshops with stakeholders from multiple sectors of the health system, and ascertainment of field notes and geographic coordinates for group meeting locations and HIV healthcare facilities. Quantitative survey data were analyzed using STATA IC/13. Longitude and latitude coordinates were mapped to county boundaries using Esri ArcMap. Qualitative data obtained from stakeholder meetings and field notes were analyzed thematically. Results: Of the 105 surveyed microfinance groups, 77 met eligibility criteria. Eligible groups had been in existence from 6 months to 18 years and had an average of 22 members. The majority (64%) of groups had at least one member who owned a smartphone. The definition of "active" membership and model of saving and lending differed across groups. Stakeholders perceived the community-based intervention and trial procedures to be acceptable given the minimal risks to participants and the potential to improve HIV treatment outcomes while facilitating care integration. Potential challenges identified by stakeholders included possible conflicts between the trial and existing community-based interventions, fear of group disintegration prior to trial end, clinicians' inability to draw blood for viral load testing in the community, and deviations from standard care protocols. Conclusions: This study revealed that it was feasible to recruit the number of microfinance groups necessary to ensure that our clinical trial was sufficient powered. Elicitation of stakeholder feedback confirmed that the planned intervention was largely acceptable and was critical to identifying challenges prior to implementation

Microfinance, retention in care, and mortality among patients enrolled in HIV 2 Care in East Africa

Objective: To measure associations between participation in community-based microfinance groups, retention in HIV care, and death among people with HIV (PWH) in low-resource settings. Design and methods: We prospectively analyzed data from 3609 patients enrolled in an HIV care program in western Kenya. HIV patients who were eligible and chose to participate in a Group Integrated Savings for Health Empowerment (GISHE) microfinance group were matched 1 : 2 on age, sex, year of enrollment in HIV care, and location of initial HIV clinic visit to patients not participating in GISHE. Follow-up data were abstracted from medical records from January 2018 through February 2020. Logistic regression analysis examined associations between GISHE participation and two outcomes: retention in HIV care (i.e. >1 HIV care visit attended within 6 months prior to the end of follow-up) and death. Socioeconomic factors associated with HIV outcomes were included in adjusted models. Results: The study population was majority women (78.3%) with a median age of 37.4 years. Microfinance group participants were more likely to be retained in care relative to HIV patients not participating in a microfinance group [adjusted odds ratio (aOR) = 1.31, 95% confidence interval (CI) 1.01–1.71; P = 0.046]. Participation in group microfinance was associated with a reduced odds of death during the follow-up period (aOR = 0.57, 95% CI 0.28–1.09; P = 0.105). Conclusion: Participation in group-based microfinance appears to be associated with better HIV treatment outcomes. A randomized trial is needed to assess whether microfinance groups can improve clinical and socioeconomic outcomes among PWH in similar settings

A randomized clinical trial of a group cognitive-behavioral therapy to reduce alcohol use among human immunodeficiency virus-infected outpatients in western Kenya

Background and aims: Culturally relevant and feasible interventions are needed to address limited professional resources in sub-Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive-behavioral therapy (CBT) intervention to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. Design: Randomized clinical trial. Setting: A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration. Participants: A total of 614 HIV-infected outpatients [312 CBT; 302 healthy life-styles (HL); 48.5% male; mean age: 38.9 years; mean education 7.7 years] who reported a minimum of hazardous or binge drinking. Intervention and comparator: A culturally adapted six-session gender-stratified group CBT intervention compared with HL education, each delivered by paraprofessionals over six weekly 90-minute sessions with a 9-month follow-up. Measurements: Primary outcome measures were percentage of drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the time-line follow-back from baseline to 9 months post-intervention. Exploratory analyses examined unprotected sex and number of partners. Findings: Median attendance was six sessions across condition. Retention at 9 months post-intervention was high and similar by condition: CBT 86% and HL 83%. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period, PDD - CBT = 3.64 (0.696), HL = 5.72 (0.71), mean difference 2.08, 95% confidence interval (CI) = 0.13 - 4.04; DDD - CBT = 0.66 (0.96), HL = 0.98 (0.098), mean difference = 0.31, 95% CI = 0.05 - 0.58. Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up. Conclusions: A cognitive-behavioral therapy intervention was more efficacious than healthy lifestyles education in reducing alcohol use among HIV-infected Kenyan outpatient drinkers

Detection of types of HPV among HIV‐infected and HIV‐uninfected Kenyan women undergoing cryotherapy or loop electrosurgical excision procedure

OBJECTIVE: To assess the baseline types of HPV infection among HIV-positive and HIV-negative women in western Kenya undergoing cryotherapy or loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia. METHODS: A prospective observational study was conducted of baseline HPV characteristics women undergoing visual inspection with acetic acid (VIA) and cryotherapy or LEEP. After a positive VIA in HIV-positive and HIV-negative women, data on demographics, CD4 count, and use of antiretroviral therapy and a cervical swab were collected. HPV typing was performed using the Roche Linear Array. RESULTS: Of 175 participants, 86 (49.1%) were HIV-positive and had a higher prevalence of low-risk HPV types (odds ratio [OR] 5.28, P=0.005) compared with HIV-negative women. The most common high-risk (HR)-HPV types in HIV-positive women were HPV 16 (13.9%) and HPV 18 (11.1%). HIV-positive women requiring LEEP were more likely to have HR-HPV types (OR 6.67, P=0.012) and to be infected with multiple HR-HPV types (OR 7.79, P=0.024) compared to those undergoing cryotherapy. CONCLUSION: HIV-positive women requiring LEEP versus cryotherapy had a higher prevalence of any HR-HPV type and multiple HR-HPV types. There were no such differences in HPV types identified among HIV-negative women