Incidence, Clearance and Persistence of Penile High-Risk Human Papillomavirus among Rwandan Men who have Sex with Men.

BACKGROUND: Little is known about penile high-risk HPV among MSM in low-and-middle income countries. We aimed to determine the incidence, clearance and persistence of penile hrHPV among Rwandan MSM. METHODS: We enrolled 350 MSM (345 with valid HPV results), aged ≥18 years, at each visit (6-12 months apart), we collected penile PreservCyt specimens and blood for HPV and HIV testing, socio-demographic and behavioral variables. HPV testing was performed using the Ampfire assay. Penile hrHPV incidence and clearance/1,000 person-months of follow-up (PMF), prevalent- and incident-persistence were computed and compared by HIV status. RESULTS: The mean age was 27.7 ± 6.7 years and 19.4% were living with HIV. Penile hrHPV incidence was 34.8 (95% CI: 29.1, 41.8)/1,000 PMF. HPV16 (11.7, CI 9.26, 14.9) and HPV59 (6.1, CI 4.52, 8.39) had the highest incidence rates. Prevalent- and incident-persistence were 47.5% and 46.6%, respectively. HPV66 (33.3%), HPV52 (30.8%) and HPV16 (29.2%) had the highest prevalent-persistence and HPV33 (53.8%), HPV31 (46.7%) and HPV16 (42.6%) the highest incident-persistence. No differences were found by HIV status except for HPV45 (higher in MSM with HIV). CONCLUSION: We found high incidence and prevalent/incident-persistence of penile hrHPV among Rwandan MSM. This highlights the importance of preventive strategies for HPV-associated anogenital cancers.

Metabolic causes of liver disease among adults living with HIV from low- and middle-income countries: a cross-sectional study.

INTRODUCTION: Liver disease is a leading cause of morbidity and mortality among persons living with HIV (PLHIV). While chronic viral hepatitis has been extensively studied in low- and middle-income countries (LMICs), there is limited information about the burden of metabolic disorders on liver disease in PLHIV. METHODS: We conducted a cross-sectional analysis of baseline data collected between October 2020 and July 2022 from the IeDEA-Sentinel Research Network, a prospective cohort enrolling PLHIV ≥40 years on antiretroviral treatment (ART) for ≥6 months from eight clinics in Asia, Americas, and central, East, southern and West Africa. Clinical assessments, laboratory testing on fasting blood samples and liver stiffness measurement (LSM)/controlled attenuation parameter (CAP) by vibration-controlled transient elastography were performed. Multivariable logistic regression models assessed factors associated with liver fibrosis (LSM ≥7.1 kPa) and steatosis (CAP ≥248 dB/m). Population attributable fraction (PAF) of each variable associated with significant liver fibrosis was estimated using Levin's formula. RESULTS: Overall, 2120 PLHIV (56% female, median age 50 [interquartile range: 45-56] years) were included. The prevalence of obesity was 19%, 12% had type 2 diabetes mellitus (T2DM), 29% had hypertension and 53% had dyslipidaemia. The overall prevalence of liver fibrosis and steatosis was 7.6% (95% confidence interval [CI] 6.1-8.4) and 28.4% (95% CI 26.5-30.7), respectively, with regional variability. Male sex at birth (odds ratio [OR] 1.62, CI 1.10-2.40), overweight/obesity (OR = 2.50, 95% CI 1.69-3.75), T2DM (OR 2.26, 95% CI 1.46-3.47) and prolonged exposure to didanosine (OR 3.13, 95% CI 1.46-6.49) were associated with liver fibrosis. Overweight/obesity and T2DM accounted for 42% and 11% of the PAF for liver fibrosis, while HBsAg and anti-HCV accounted for 3% and 1%, respectively. Factors associated with steatosis included overweight/obesity (OR 4.25, 95% CI 3.29-5.51), T2DM (OR 2.06, 95% CI 1.47-2.88), prolonged exposure to stavudine (OR 1.69, 95% CI 1.27-2.26) and dyslipidaemia (OR 1.68, 95% CI 1.31-2.16). CONCLUSIONS: Metabolic disorders were significant risk factors for liver disease among PLHIV in LMICs. Early recognition of metabolic disorders risk factors might be helpful to guide clinical and lifestyle interventions. Further prospective studies are needed to determine the causative natures of these findings.

Awareness and willingness to use pre-exposure prophylaxis for HIV prevention among men who have sex with men in Rwanda: findings from a web-based survey.

Introduction: Pre-exposure Prophylaxis (PrEP) is a daily pill aimed at reducing HIV transmission risk when taken as prescribed. It's highly recommended for high-risk Men who have sex with Men (MSM). This study aimed to assess PrEP awareness and willingness to use it among Rwandan MSM, a critical aspect given PrEP's proven effectiveness. The findings are expected to inform policy decisions and further advance the implementation of PrEP strategies. Methods: This is a cross-sectional study design that utilized a web-based survey conducted between April and June 2019 to assess awareness and willingness to use PrEP among sexually active MSM in Rwanda. A snowball sampling technique was used to recruit participants via social media such as WhatsApp and e-mail. Eligibility criteria included being sexually active, aged ≥18 years, self-identifying as MSM, residing in Rwanda, self-reported engagement in receptive or insertive anal sex in the last 12 months, and self-reported HIV-negative serostatus. We assessed two primary outcomes: PrEP awareness (having ever heard of PrEP) and willingness to use PrEP within one month of completing the survey. Multivariable logistic regression was performed to identify participant characteristics associated with PrEP awareness and willingness to use it. Results: Out of 521 participants, the majority (73%) demonstrated awareness of PrEP. Factors linked to PrEP awareness included residing outside the capital, Kigali, being in the 18-29 age group, having higher education levels, perceiving a benefit from PrEP, and engaging in vaginal sex with a woman while using a condom in the last year. Additionally, 96% of participants expressed a strong willingness to use PrEP. Conclusion: Rwandan MSM exhibits a high level of PrEP awareness, notably associated with factors like location, age, education, perceived benefits, and condom use. The study also revealed a strong willingness to use PrEP, indicating promising prospects for its adoption among this group. These findings highlight the need for targeted awareness campaigns, personalized interventions, and comprehensive sexual health education to promote PrEP adoption and strengthen HIV prevention efforts among Rwandan MSM.

HPV vaccination in Africa in the COVID-19 era: a cross-sectional survey of healthcare providers' knowledge, training, and recommendation practices.

Introduction: Although the burden of cervical cancer in Africa is highest, HPV vaccination coverage remains alarmingly low in this region. Providers' knowledge and recommendation are key drivers of HPV vaccination uptake. Yet, evidence about providers' knowledge and recommendation practices about the HPV vaccine against a backdrop of emerging vaccine hesitancy fueled by the COVID-19 pandemic is lacking in Africa. Methods: A cross-sectional study was conducted in 2021-2022 among healthcare providers involved in cervical cancer prevention activities in Africa. They were invited to report prior training, the availability of the HPV vaccine in their practice, whether they recommended the HPV vaccine, and, if not, the reasons for not recommending it. Their knowledge about the HPV vaccine was assessed through self-reporting (perceived knowledge) and with three pre-tested knowledge questions (measured knowledge). Results: Of the 153 providers from 23 African countries who responded to the survey (mean age: 38.5 years, SD: 10.1), 75 (54.0%) were female and 97 (63.4%) were based In countries with national HPV immunization programs. Overall, 57 (43.8%) reported having received prior training on HPV vaccine education/counseling, and 40 (37.4%) indicated that the HPV vaccine was available at the facility where they work. Most respondents (109, 83.2%) reported recommending the HPV vaccine in their practice. Vaccine unavailability (57.1%), lack of effective communication tools and informational material (28.6%), and need for adequate training (28.6%) were the most commonly reported reasons for not recommending the HPV vaccine. While 63 providers (52.9%) reported that their knowledge about HPV vaccination was adequate for their practice, only 9.9% responded correctly to the 3 knowledge questions. Conclusion: To increase HPV vaccination coverage and counter misinformation about this vaccine in Africa, adequate training of providers and culturally appropriate educational materials are needed to improve their knowledge of the HPV vaccine and to facilitate effective communication with their patients and the community.

Facility-Based Indicators to Manage and Scale Up Cervical Cancer Prevention and Care Services for Women Living With HIV in Sub-Saharan Africa: a Three-Round Online Delphi Consensus Method.

BACKGROUND: Of women with cervical cancer (CC) and HIV, 85% live in sub-Saharan Africa, where 21% of all CC cases are attributable to HIV infection. We aimed to generate internationally acceptable facility-based indicators to monitor and guide scale up of CC prevention and care services offered on-site or off-site by HIV clinics. METHODS: We reviewed the literature and extracted relevant indicators, grouping them into domains along the CC control continuum. From February 2021 to March 2022, we conducted a three-round, online Delphi process to reach consensus on indicators. We invited 106 experts to participate. Through an anonymous, iterative process, participants adapted the indicators to their context (round 1), then rated them for 5 criteria on a 5-point Likert-type scale (rounds 2 and 3) and then ranked their importance (round 3). RESULTS: We reviewed 39 policies from 21 African countries and 7 from international organizations; 72 experts from 15 sub-Saharan Africa countries or international organizations participated in our Delphi process. Response rates were 34% in round 1, 40% in round 2, and 44% in round 3. Experts reached consensus for 17 indicators in the following domains: primary prevention (human papillomavirus prevention, n = 2), secondary prevention (screening, triage, treatment of precancerous lesions, n = 11), tertiary prevention (CC diagnosis and care, n = 2), and long-term impact of the program and linkage to HIV service (n = 2). CONCLUSION: We recommend that HIV clinics that offer CC control services in sub-Saharan Africa implement the 17 indicators stepwise and adapt them to context to improve monitoring along the CC control cascade.

Association Between Clinical Encounter Frequency and HIV-Related Stigma Among Newly-Diagnosed People Living with HIV in Rwanda.

HIV-related stigma in healthcare settings remains a key barrier to engaging people living with HIV (PLHIV) in care. This study investigated the association between clinical encounter frequency and HIV-related anticipated, enacted, and internalized stigma among newly-diagnosed PLHIV in Rwanda. From October 2020 to May 2022, we collected data from adult PLHIV on antiretroviral therapy (ART) in Kigali, Rwanda who were participating in a randomized, controlled trial testing early entry into differentiated care at 6 months after ART initiation. We measured anticipated HIV stigma with five-point Likert HIV Stigma Framework measures, enacted stigma with the four-point Likert HIV/AIDS Stigma Instrument, and internalized stigma with the four-point Likert HIV/AIDS Stigma Instrument. We used multivariable linear regression to test the associations between clinical encounter frequency (average inter-visit interval ≥ 50 days vs. < 50 days) and change in mean anticipated, enacted and internalized HIV stigma over the first 12 months in care. Among 93 individuals enrolled, 76 had complete data on encounter frequency and stigma measurements and were included in the present analysis. Mean internalized stigma scores of all participants decreased over the first 12 months in care. Anticipated and enacted stigma scores were low and did not change significantly over time. There was no association between encounter frequency and change in internalized stigma. In this pilot study of newly-diagnosed Rwandan PLHIV with relatively low levels of HIV-related stigma, clinical encounter frequency was not associated with change in stigma. Additional research in diverse settings and with larger samples is necessary to further explore this relationship.

Low birth weight among infants and pregnancy outcomes among women living with HIV and HIV-negative women in Rwanda.

Introduction: In utero exposure to HIV and/or triple antiretroviral therapy (ART) have been shown to be associated with preterm births and low birth weight (LBW), but data from low-resources settings with high burden of HIV remain limited. This study utilized retrospective data to describe pregnancy outcomes among Rwandan women living with HIV (WLHIV) and HIV-negative women and to assess the association of HIV and ART with LBW. Methods: This study used data from a large cohort of WLHIV and HIV-negative women in Rwanda for a cross-sectional analysis. Retrospective data were collected from antenatal care (ANC), delivery, and Prevention of Mother to Child Transmission (PMTCT) registries within the Central Africa International Epidemiology Databases to Evaluate AIDS (CA-IeDEA) in Rwanda. Data from women with documented HIV test results and known pregnancy outcomes were included in the analysis. Analyses for predictors of LBW (< 2,500 g) were restricted to singleton live births. Logistic models were used to identify independent predictors and estimate the odd ratios (OR) and 95% confidence intervals (CI) measuring the strength of their association with LBW. Results and discussion: Out of 10,608 women with known HIV status and with documented pregnancy outcomes, 9.7% (n = 1,024) were WLHIV. We restricted the sample to 10,483 women who had singleton live births for the analysis of the primary outcome, LBW. Compared with HIV-negative women, WLHIV had higher rates of stillbirth, preterm births, and LBW babies. Multivariable model showed that WLHIV and primigravidae had higher odds of LBW. Lower maternal weight and primigravidae status were associated with greater odds of LBW. Among WLHIV, the use of ART was associated with significantly lower odds of LBW in a bivariate analysis. Even in a sample of relatively healthier uncomplicated pregnancies and women who delivered in low-risk settings, WLHIV still had higher rates of poor pregnancy outcomes and to have LBW infants compared to women without HIV. Lower maternal weight and primigravidae status were independently associated with LBW. Given that supplementary nutrition to malnourished pregnant women is known to decrease the incidence of LBW, providing such supplements to lower-weight WLHIV, especially primigravidae women, might help reduce LBW.

Awareness and Willingness to Use HIV Infection Pre-Exposure Prophylaxis among Rwandan Men Who Have Sex with Men: Findings from a Web-based Survey.

Introduction: Pre-exposure Prophylaxis (PrEP) is a daily pill intended to reduce the risk of acquiring Human Immunodeficiency Virus (HIV) when taken as prescribed. It is strongly recommended for Men who have sex with Men (MSM) at high risk of HIV transmission to minimize infection risk. Despite its proven effectiveness, there is a lack of information about awareness and willingness to use PrEP among Rwandan MSM. In the context of HIV acquisition, the purpose of this study was to ascertain the awareness and willingness to use PrEP among high-risk Rwandan MSM. The findings of this research will provide valuable perspectives to mold policy and direct the effective execution of PrEP within the country. Method: This is a cross-sectional study design that utilized a web-based survey conducted between April and June 2019 to assess awareness and willingness to use PrEP among sexually active MSM in Rwanda. A snowball sampling technique was used to recruit participants who were contacted via social medial such as WhatsApp and e-mail. To be eligible, participants were supposed to be sexually active, aged ≥18 years, self-identify as MSM, residence in Rwanda, self-reported engagement in receptive or insertive anal sex in the last 12 months, and self-reported HIV-negative sero-status. We assessed two primary outcomes: PrEP awareness (having ever heard of PrEP) and willingness to use PrEP within one month of completing the survey. Multivariable logistic regression was performed to identify participant characteristics associated with PrEP awareness and willingness to use it. Results: Among the 521 participants included in the analysis, 63% were aged below 24 years. The majority (73%) demonstrated awareness of PrEP. Factors associated with PrEP awareness included residing outside of the capital, Kigali, as opposed to living in Kigali (adjusted odds ratio [aOR] 2.35, 95% confidence interval [CI] 1.40-3.97), being in the age groups 18-24 years (aOR 2.28, 95% CI: 1.03-5.01) or 25-29 years (aOR 3.06, 95% CI 1.35-6.93) compared to those aged 30 or older, having higher education levels, such as completing secondary education (aOR 1.76, 95% CI 1.01-3.06) or university education (aOR 2.65, 95% CI 1.18-5.96) in contrast to having no education. Lastly, perceiving a benefit from PrEP (aOR 9.52, 95% CI 4.27-21.22), and engaging in vaginal sex with a woman using a condom in the last 12 months (aOR 1.82, 95% CI 1.14-2.91) versus not. Impressively, 96% of participants expressed a strong willingness to use PrEP. Conclusion: Among Rwandan MSM, there is a high level of awareness of PrEP, notably associated with factors such as residing outside Kigali, younger age, higher education, perceived benefits of PrEP and condom use during vaginal sex in the past year. Furthermore, a significant portion of participants demonstrated an intense desire to use PrEP, suggesting promising possibilities for its extensive implementation among this group of people. The findings from this study emphasize the importance of implementing highly focused awareness campaigns, personalized intervention, and comprehensive sexual health education programs in order to enhance the adoption of PrEP and bolster HIV prevention initiatives among the Rwandan population of MSM.

Experiences of stigma and HIV care engagement in the context of Treat All in Rwanda: a qualitative study.

BACKGROUND: 'Treat All' policies recommending immediate antiretroviral therapy (ART) soon after HIV diagnosis for all people living with HIV (PLHIV) are now ubiquitous in sub-Saharan Africa. While early ART initiation and retention is effective at curtailing disease progression and transmission, evidence suggests that stigma may act as a barrier to engagement in care. This study sought to understand the relationships between HIV stigma and engagement in care for PLHIV in Rwanda in the context of Treat All. METHODS: Between September 2018 and March 2019, we conducted semi-structured, qualitative interviews with adult PLHIV receiving care at two health centers in Kigali, Rwanda. We used a grounded theory approach to data analysis to develop conceptual framework describing how stigma influences HIV care engagement in the context of early Treat All policy implementation in Rwanda. RESULTS: Among 37 participants, 27 (73%) were women and the median age was 31 years. Participants described how care engagement under Treat All, including taking medications and attending appointments, increased their visibility as PLHIV. This served to normalize HIV and use of ART but also led to high levels of anticipated stigma in the health center and community at early stages of treatment. Enacted stigma from family and community members and resultant internalized stigma acted as additional barriers to care engagement. Nonetheless, participants described how psychosocial support from care providers and family members helped them cope with stigma and promoted continued engagement in care. CONCLUSIONS: Treat All policy in Rwanda has heightened the visibility of HIV at the individual and social levels, which has influenced HIV stigma, normalization, psychosocial support and care engagement in complex ways. Leveraging the individual and community support described by PLHIV to deliver evidence-based, peer or provider-delivered stigma reduction interventions may aid in attaining Treat All goals.

Toward 70% cervical cancer screening coverage: Technical challenges and opportunities to increase access to human papillomavirus (HPV) testing.

The World Health Organization (WHO) has called for the elimination of cervical cancer as a public health problem. Cervical cancer screening through human papillomavirus (HPV) testing is a core component of the strategy for elimination, with a set target of screening 70% of women twice in their lifetimes. In this review, we discuss technical barriers and opportunities to increase HPV screening globally.

Comparison of AmpFire and MY09/11 assays for HPV genotyping in anogenital specimen of Rwandan men who have sex with men.

Introduction: The AmpFire HPV genotyping Assay (Atila Biosystems, Mountain View, CA, USA) is a new test for which there are few data regarding its analytic performance and reliability. Using anal and penile swab specimens from a cohort study of men who have sex with men (MSM) in Rwanda, we compared high-risk HPV (hrHPV) detection by AmpFire done at two laboratories, one at University of California San Francisco (UCSF) and the other Rwanda Military Hospital, and well-validated MY09/11-based assay done at UCSF. Methods: Anal and penile specimens collected from 338 MSM from March 2016 to September 2016 were tested for high-risk HPV genotypes (hrHPV) by MY09/11, AmpFire UCSF and AmpFire RMH. Cohen's kappa coefficient was used to test for reproducibility. Results: The hrHPV positivity by MY09/11 and AmpFire UCSF was 13% and 20.7% (k = 0.73) for anal specimens and was 26.3% and 32.6% (k = 0.67) for penile specimens. Specifically, good reproducibility was for types 16 and 18 (k = 0.69 and k = 0.71) for anal specimens and (k = 0.50 and k = 0.72) for penile specimens. The hrHPV positivity by AmpFire at UCSF and RMH was 20.7% for both laboratories (k = 0.87) for anal specimens and was 34.9% and 31.9% (k = 0.89) for penile specimens. Specifically, excellent reproducibility was for types 16 and 18 for anal specimens (k = 0.80 and k = 1.00) and penile specimens (k = 0.85 and k = 0.91). Conclusion: Results show that MY09/11 and AmpFire assays have good reproducibility while the AmpFire UCSF and RMH assays have excellent reproducibility. These results show that AmpFire is a promising HPV genotyping test.

The first Choosing Wisely Africa conference: a roadmap to value-based cancer care in Africa (16th December 2022, Senegal).

The Choosing Wisely campaign was formally launched in 2012 and a decade later, the inaugural Choosing Wisely Africa conference was held in Dakar, Senegal on 16 December 2022 supported by ecancer. Academic partners included Ministere de la Sante et de I'Action Sociale, Senegalese Association of Palliative Care, Federation Internationale des Soins Palliatifs, Universite Cheikh Anta diop de Dakar, Societe Senegalaise de Cancerologie and King's College London. There were around 70 delegates attending in person mostly from Senegal and a further 30 joining virtually. Ten speakers gave insight into Choosing Wisely from an African perspective and Dr's Fabio Moraes and Frederic Ivan Ting shared the Choosing Wisely experience from Brazil and the Philippines, respectively. This report therefore shares the highlights of the first Choosing Wisely Africa conference guided by topics discussed.

An analysis of the African cancer research ecosystem: tackling disparities.

Disparities in cancer research persist around the world. This is especially true in global health research, where high-income countries (HICs) continue to set global health priorities further creating several imbalances in how research is conducted in low and middle-income countries (LMICs). Cancer research disparities in Africa can be attributed to a vicious cycle of challenges in the research ecosystem ranging from who funds research, where research is conducted, who conducts it, what type of research is conducted and where and how it is disseminated. For example, the funding chasm between HICs and LMICs contributes to inequities and parachutism in cancer research. Breaking the current cancer research model necessitates a thorough examination of why current practices and norms exist and the identification of actionable ways to improve them. The cancer research agenda in Africa should be appropriate for the African nations and continent. Empowering African researchers and ensuring local autonomy are two critical steps in moving cancer research towards this new paradigm.

Association Between Time to Antiretroviral Therapy and Loss to Care Among Newly Diagnosed Rwandan People Living with Human Immunodeficiency Virus.

Despite improved clinical outcomes of initiating antiretroviral therapy (ART) soon after diagnosis, conflicting evidence exists regarding the impact of same-day ART initiation on subsequent clinical outcomes. We aimed to characterize the associations of time to ART initiation with loss to care and viral suppression in a cohort of newly diagnosed people living with HIV (PLHIV) entering care after Rwanda implemented a national "Treat All" policy. We conducted a secondary analysis of routinely collected data of adult PLHIV enrolling in HIV care at 10 health facilities in Kigali, Rwanda. Time from enrollment to ART initiation was categorized as same day, 1-7 days, or >7 days. We examined associations between time to ART and loss to care (>120 days since last health facility visit) using Cox proportional hazards models, and between time to ART and viral suppression using logistic regression. Of 2,524 patients included in this analysis, 1,452 (57.5%) were women and the median age was 32 (interquartile range: 26-39). Loss to care was more frequent among patients who initiated ART on the same day (15.9%), compared with those initiating ART 1-7 days (12.3%) or >7 days (10.1%), p < .001. In multivariable analyses, same-day ART initiation was associated with a greater hazard of loss to care compared with initiating >7 days after enrollment (adjusted hazard ratio 1.39, 95% confidence interval: 1.04-1.85). A total of 1,698 (67.3%) had available data on viral load measured within 455 days after enrollment. Of these, 1,476 (87%) were virally suppressed. A higher proportion of patients initiating ART on the same day were virally suppressed (89%) compared with those initiating 1-7 days (84%) or >7 days (88%) after enrollment. This association was not statistically significant. Our findings suggest that ensuring adequate, early support for PLHIV initiating ART rapidly may be important to improve retention in care for newly diagnosed PLHIV in the era of Treat All.

Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda.

Background: High-risk human papillomavirus (hrHPV) may cause more than 99% of cervical cancers worldwide. Little is known about performance differences in tests for hrHPV. Objective: This study analysed agreement for detection of hrHPV between the established, clinically validated Xpert HPV assay and the novel isothermal amplification-based AmpFire HPV genotyping assay. Methods: This study was nested in a larger project on cervical cancer screening among approximately 5000 women living with HIV in Kigali, Rwanda. This sub-study included 298 participants who underwent initial screening for cervical cancer using the Xpert HPV assay and visual inspection with acetic acid in 2017 and tested positive by either or both. Participants were rescreened using colposcopy, and cervical samples were collected between June 2018 and June 2019. Samples were then tested for HPV using the Xpert HPV assay and AmpFire HPV genotyping assay. Agreement between results from both tests was analysed using an exact version of McNemar test and chi-square test. Results: Overall agreement and kappa value for detection of hrHPV by Xpert and AmpFire were 89% and 0.77 (95% confidence interval: 0.70-0.85). AmpFire was marginally more likely to diagnose hrHPV-positive than Xpert (p = 0.05), due primarily to the extra positivity for HPV16 (p < 0.001). Conclusion: Overall, there was good to excellent agreement between the Xpert and AmpFire when testing hrHPV types among women living with HIV. AmpFire was more likely to test extra cases of HPV16, the most carcinogenic HPV type, but the clinical meaning of detecting additional HPV16 infections remains unknown.

COVID-19 associated changes in HIV service delivery over time in Central Africa: Results from facility surveys during the first and second waves of the pandemic.

INTRODUCTION: The COVID-19 pandemic has impacted population health around the globe, directly and indirectly. The objective of this study was to document changes in HIV care associated with the COVID-19 pandemic at selected clinics in Central Africa, along with clinic-level strategies for minimizing disruptions in HIV care and treatment for people with HIV (PWH). METHODS: A 51-item questionnaire on COVID-19 pandemic-associated changes in HIV service delivery was completed by clinicians involved in HIV care at 21 clinics in five countries participating in Central Africa International epidemiology Databases to Evaluate AIDS (CA-IeDEA). The survey was completed at two timepoints: June-July 2020 and October 2020 to February 2021. Descriptive statistics were used to characterize changes in HIV care and related services. RESULTS: While 81% of sites reported at least one negative consequence of COVID-19 for clinic operations during the first survey, none reported suspending antiretroviral therapy (ART) initiation services for new patients, and 24% reported adopting telemedicine. In the follow-up survey, fewer sites (48%) reported at least one disruption to clinic operations, and more sites reported mitigation strategies, including expanding rapid ART initiation services and providing extra supplies of ART medications to reduce visit frequency. In the follow-up survey, more sites, especially in Rwanda, reported stockouts of commodities, including HIV and viral load testing and HIV pre-exposure prophylaxis. More than one-fifth of sites reported stockouts of second- or third-line ART at each survey timepoint. CONCLUSIONS: While the initial wave of the COVID-19 pandemic resulted in concerning disruptions to HIV service delivery at CA-IeDEA sites, most of these disruptions attenuated over time, and many sites introduced measures to help PWH avoid frequent visits to the clinic for care and medications. The impact of HIV commodity stockouts and clinic mitigation strategies on treatment outcomes needs to be assessed.

Long-term human papillomavirus vaccination effectiveness and immunity in Rwandan women living with and without HIV: a study protocol.

INTRODUCTION: Prophylactic human papillomavirus (HPV) vaccines have been shown to be highly effective in protecting women against cervical infections, high-grade abnormalities and cancer caused by the targeted HPV types. However, the evidence for their effectiveness in women living with HIV (WLWH) is less clear. METHODS: WLWH and HIV-negative women who likely did (birth cohorts 1996 and later) and WLWH and HIV(-) negative who likely did not (birth cohorts before 1996) receive HPV vaccination (n=3028; 757 participants for each of the four groups). Between groups, we will compare cervicovaginal, anal and oral prevalent and 6-12 month persistent HPV6/11/16/18 infections as measured using a modified AmpFire HPV genotyping assay that tests for 15 high-risk or intermediate-risk HPV genotypes, HPV6 and HPV11. We will also compare the HPV immune response in HPV-vaccinated WLWH to HPV-vaccinated HIV-negative women using an anti-HPV16 and anti-HPV18 ELISA. Vaccination status will be confirmed through national vaccination records. ANALYSIS: We will calculate point prevalence and prevalence of 6-12 month persisting infections by individual HPV-type specific infections and groups of infections for each anatomic site and for each group of women. Results will be stratified by age at vaccination, age at enrolment and the number of doses (3 vs 2) as well as other factors possibly associated with HPV prevalence. Differences in endpoints between groups, overall and between subgroups, will be tested for statistical significance (p<0.05) using Fisher's exact or Pearson χ2 test. Differences in geometric mean titres and seropositivity will be tested for statistical significance using the Mann-Whitney and Fisher's exact tests, respectively. ETHICS AND DISSEMINATION: The study was approved by the Albert Einstein College of Medicine Institutional Review Board and the Rwanda National Ethics Committee. Results will be disseminated through publication in peer-reviewed journals.

Real-world use and outcomes of dolutegravir-containing antiretroviral therapy in HIV and tuberculosis co-infection: a site survey and cohort study in sub-Saharan Africa.

INTRODUCTION: Dolutegravir is being scaled up globally as part of antiretroviral therapy (ART), but for people with HIV and tuberculosis co-infection, its use is complicated by a drug-drug interaction with rifampicin requiring an additional daily dose of dolutegravir. This represents a disadvantage over efavirenz, which does not have a major drug-drug interaction with rifampicin. We sought to describe HIV clinic practices for prescribing concomitant dolutegravir and rifampicin, and characterize virologic outcomes among patients with tuberculosis co-infection receiving dolutegravir or efavirenz. METHODS: Within the four sub-Saharan Africa regions of the International epidemiology Databases to Evaluate AIDS consortium, we conducted a site survey (2021) and a cohort study (2015-2021). The cohort study used routine clinical data and included patients newly initiating or already receiving dolutegravir or efavirenz at the time of tuberculosis diagnosis. Patients were followed from tuberculosis diagnosis until viral suppression (<1000 copies/ml), a competing event (switching ART regimen; loss to program/death) or administrative censoring at 12 months. RESULTS: In the survey, 86 of 90 (96%) HIV clinics in 18 countries reported prescribing dolutegravir to patients who were receiving rifampicin as part of tuberculosis treatment, with 77 (90%) reporting that they use twice-daily dosing of dolutegravir, of which 74 (96%) reported having 50 mg tablets available to accommodate twice-daily dosing. The cohort study included 3563 patients in 11 countries, with 67% newly or recently initiating ART. Among patients receiving dolutegravir (n = 465), the cumulative incidence of viral suppression was 58.9% (95% confidence interval [CI]: 54.3-63.3%), switching ART regimen was 4.1% (95% CI: 2.6-6.2%) and loss to program/death was 23.4% (95% CI: 19.7-27.4%). Patients receiving dolutegravir had improved viral suppression compared with patients receiving efavirenz who had a tuberculosis diagnosis before site dolutegravir availability (adjusted subdistribution hazard ratio [aSHR]: 1.47, 95% CI: 1.28-1.68) and after site dolutegravir availability (aSHR 1.28, 95% CI: 1.08-1.51). CONCLUSIONS: At a programmatic level, dolutegravir was being widely prescribed in sub-Saharan Africa for people with HIV and tuberculosis co-infection with a dose adjustment for the drug-drug interaction with rifampicin. Despite this more complex regimen, our cohort study revealed that dolutegravir did not negatively impact viral suppression.

Viral Load Status Before Switching to Dolutegravir-Containing Antiretroviral Therapy and Associations With Human Immunodeficiency Virus Treatment Outcomes in Sub-Saharan Africa.

BACKGROUND: Dolutegravir is being rolled out globally as part of preferred antiretroviral therapy (ART) regimens, including among treatment-experienced patients. The role of viral load (VL) testing before switching patients already on ART to a dolutegravir-containing regimen is less clear in real-world settings. METHODS: We included patients from the International epidemiology Databases to Evaluate AIDS consortium who switched from a nevirapine- or efavirenz-containing regimen to one with dolutegravir. We used multivariable cause-specific hazards regression to estimate the association of the most recent VL test in the 12 months before switching with subsequent outcomes. RESULTS: We included 36 393 patients at 37 sites in 5 countries (Democratic Republic of the Congo, Kenya, Rwanda, Tanzania, Uganda) who switched to dolutegravir from July 2017 through February 2020, with a median follow-up of approximately 11 months. Compared with those who switched with a VL <200 copies/mL, patients without a recent VL test or with a preswitch VL ≥1000 copies/mL had significantly increased hazards of an incident VL ≥1000 copies/mL (adjusted hazard ratio [aHR], 2.89; 95% confidence interval [CI], 1.99-4.19 and aHR, 6.60; 95% CI, 4.36-9.99, respectively) and pulmonary tuberculosis or a World Health Organization clinical stage 4 event (aHR, 4.78; 95% CI, 2.77-8.24 and aHR, 13.97; 95% CI, 6.62-29.50, respectively). CONCLUSIONS: A VL test before switching to dolutegravir may help identify patients who need additional clinical monitoring and/or adherence support. Further surveillance of patients who switched to dolutegravir with an unknown or unsuppressed VL is needed.