Feasibility, validity and acceptability of self-collected samples for human papillomavirus (HPV) testing in rural Malawi

AimThe World Health Organization (WHO) recently endorsed human papillomavirus (HPV) testing as a cervical cancer screening method in countries without established programs. Self-collection for HPV testing may be an effective way to expand screening. Our objective was to assess the feasibility, validity, and acceptability of self-collection for HPV testing in a population of care-seeking, unscreened women in rural Malawi.MethodsWe enrolled women reporting to a rural Malawian clinic from January to August 2015. Participants were offered the option to self-collect a vaginal sample and the study clinician collected a cervical sample for HPV testing. Using the clinician-collected sample as the reference standard, we calculated a kappa statistic, sensitivity, and specificity by hr-HPV type. Participants also received a brief survey assessing acceptability of the procedure.ResultsAmong the 199 enrolled women, 22% had any high risk-HPV. Comparing self- and clinician-collected samples for HPV testing, we found generally high agreement (κ = 0.66-0.90) and high specificity (98%-100%), but varied sensitivity (50%-91%) for different types of hr-HPV. We also found that self-collection was acceptable, with 98% of women reporting it was easy to do and 99% reporting willingness to do so again.ConclusionsWHO guidelines recommend that treatment is available immediately after a positive screening test for clinic-based cervical cancer screening programs. Our findings demonstrate that self-collection of samples for HPV testing is a feasible and acceptable method of cervical cancer screening in this rural Malawian population. High agreement between the self- and clinician-collected samples and high levels of acceptability among women in the study suggest that self-collection of vaginal samples for HPV testing may be effectively incorporated into screening programs among rural, largely unscreened populations

HIV pre-exposure prophylaxis was associated with no impact on sexually transmitted infection prevalence in a high-prevalence population of predominantly men who have sex with men, Germany, 2018 to 2019

Introduction: Despite increased use of pre-exposure prophylaxis (PrEP) in Germany, HIV infection rates are not declining and little is known about how this prevention method affects the prevalence of sexually transmitted infections (STI) among men who have sex with men (MSM). Aim: We studied, in a large multicentre cohort, STI point prevalence, co-infection rates, anatomical location and influence of PrEP. Methods: The BRAHMS study was a prospective cohort study conducted at 10 sites in seven major German cities that enrolled MSM reporting increased sexual risk behaviour. At screening visits, MSM were tested for Mycoplasma genitalium (MG), Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Treponema pallidum (TP), and given a behavioural questionnaire. With binomial regression, we estimated prevalence ratios (PR) and 95% confidence intervals (CI) for the association of PrEP and STI. Results: We screened 1,043 MSM in 2018 and 2019, with 53.0% currently using PrEP. At screening, 370 participants (35.5%) had an STI. The most common pathogen was MG in 198 (19.0%) participants, followed by CT (n = 133; 12.8%), NG (n = 105; 10.1%) and TP (n = 37; 3.5%). Among the 370 participants with at least one STI, 14.6% (n = 54) reported STI-related symptoms. Infection prevalence was highest at anorectal site (13.4% MG, 6.5% NG, 10.2% CT). PrEP use was not statistically significant in adjusted models for STI (PR: 1.10; 95% CI: 0.91–1.32), NG/CT, only NG or only CT. Conclusions: Prevalence of asymptomatic STI was high, and PrEP use did not influence STI prevalence in MSM eligible for PrEP according to national guidelines.Peer Reviewe

Preparing for future European efficacy trials of interventions to prevent HIV and other sexually transmitted infections: Lessons on willingness to participate and barriers to participation from ten German clinics serving behaviorally vulnerable men who have sex with men

Future efficacy testing of interventions to prevent HIV or other infections will require engagement of vulnerable populations. We characterized willingness to participate in a future HIV vaccine trial and barriers to participation among men who have sex with men in a 12-month German cohort study. Among 1015 participants at enrollment, 604 (60%) reported willingness, 60 (6%) were unwilling, 351 (35%) were unsure or refused to answer. Among those unwilling, the primary reason was fear of getting HIV. Among those willing, reasons included protection against HIV and furthering scientific knowledge. In a multivariable logistic regression model, higher odds of willingness to participate were seen among participants at the 12-month visit (aOR: 1.09, 95% CI: 1.04–1.15) and with prior knowledge of HIV vaccine research (aOR: 1.14, 95% CI: 1.06–1.23). Educating potential participants about vaccine research may facilitate recruitment and participation in future trials of HIV vaccine candidates and other prevention interventions

Intravaginal Practices and Prevalence of Sexual and Reproductive Tract Infections Among Women in Rural Malawi.

BACKGROUND: Many women engage in intravaginal practices (IVP) with a goal of improving genital hygiene and increasing sexual pleasure. IVP can disrupt the genital mucosa, and some studies have found that IVP increases risk of acquisition of HIV and bacterial vaginosis (BV). Limited prior research also suggests significant associations between IVP, herpes simplex virus type 2 (HSV-2), and high-risk types of human papillomavirus (HPV). METHODS: We examined associations between IVP and HPV, BV, and HSV-2 among 200 women in rural Malawi participating in a clinic-based study on sexual and reproductive tract infections. We calculated prevalence ratios for the associations between frequency and type of IVP and outcomes of HPV, BV, and HSV-2. RESULTS: Intravaginal practices were commonly performed, with 95% of women reporting current use of at least one practice. Infections were also frequently detected: 22% of the sample had at least one high risk HPV type, 51% had BV, and 50% were HSV-2 seropositive. We observed no significant associations between type of IVP, frequency of IVP, or a combined measure capturing type and frequency of IVP – and any of the infection outcomes. CONCLUSIONS: While both IVP and our outcomes of interest (BV, HPV, and HSV-2) were common in the study population, we did not detect associations between IVP type or frequency and any of the three infections. However, the high prevalence and frequency of IVP may have limited our ability to detect significant associations

Cessation of Intravaginal Practices to Prevent Bacterial Vaginosis: A Pilot Intervention in Zimbabwean Women

Objectives Intravaginal practices—including behaviours such as washing with soap or other materials, using fingers or cloth, or insertion of herbs, powders or other products to dry, cleanse or ‘tighten’ the vagina—may increase women\u27s risk of bacterial vaginosis by disrupting the vaginal microbiota. In Zimbabwe, intravaginal practices are common. The objective of this study was to assess the feasibility of an intervention based on the transtheoretical model of behaviour change (also called the ‘stages of change’ model) to encourage cessation of vaginal practices among a sample of Zimbabwean women. Methods We conducted a 12-week behaviour change intervention to encourage cessation of intravaginal practices (other than cleansing with water) among 85 Zimbabwean women who reported these practices. Results Self-reported intravaginal practices declined significantly over follow-up, with 100% of women reporting at least one intravaginal practice at enrolment compared with 8% at the final visit. However, we found no significant effect of this reduction on bacterial vaginosis prevalence in unadjusted or adjusted multivariable models (adjusted prevalence ratio for any practice vs none: 0.94, 95% CI 0.61 to 1.43). Conclusions While the intervention was successful in reducing women\u27s self-reported engagement in intravaginal practices, we observed no corresponding benefit to vaginal health

High hepatitis B vaccination coverage among a cohort of predominantly men who have sex with men in Germany

Incidence of hepatitis B virus (HBV) infection has declined dramatically since the introduction of the HBV vaccine, but gaps remain in coverage. We characterized factors associated with vaccination among individuals with sexual risk of HBV infection. The BRAHMS observational cohort enrolled men and transgender women, without HIV, aged 18–55 years, with behavioral vulnerability to sexually transmitted infections at 10 German outpatient clinics. HBV surface antigen, surface antibody, and core antibody were assessed at screening for cohort eligibility to determine HBV vaccination status. Modified Poisson regression with robust standard errors was used to calculate adjusted prevalence ratios (aPR) and 95% confidence intervals (95% CI) for factors potentially associated with prior HBV vaccination. A total of 1,042 participants were included in these cross-sectional analyses, with 831 participants (79.7%) immune to HBV due to vaccination. Knowledge around HBV vaccination recommendations (aPR: 0.87; 95% CI: 0.78–0.98). and age (aPR 40–49 vs 18–29 years: 0.88; 95% CI: 0.79–0.97) were significantly associated with a history of HBV vaccination in both the unadjusted and adjusted models. Education about the availability of vaccines and recommendations for vaccinations may improve coverage

Frequency and Predictors of HIV-Related Cognitive Impairment in East Africa: The Africa Cohort Study (AFRICOS).

BackgroundMedication adherence is a critical issue in achieving viral suppression targets, particularly in resource-limited countries. As HIV-related cognitive impairment (CI) impacts adherence, we examined frequency and predictors of CI in the African Cohort Study.SettingCross-sectional examination of enrollment data from President's Emergency Plan for AIDS Relief supported clinic sites.MethodsIn a 30-minute cognitive assessment, CI was defined as -1SD on 2 tests or -2SD on one, as compared with 429 controls. We performed univariable and multivariable logistic and linear models examining clinical and demographic factors associated with CI and global neuropsychological performance (NP-6).ResultsTwo thousand four hundred seventy-two HIV+ participants from Kenya (n = 1503), Tanzania (n = 469), and Uganda (n = 500). The mean (SD) age was 39.7 (10.7) years, and 1452 (59%) were women. The majority reported completing or partially completing primary school (n = 1584, 64%). Mean (SD) current and nadir CD4 count were 463 (249) and 204 (221) cells/mm, respectively; 1689 (68%) were on combination antiretroviral therapy. Nine hundred thirty-nine (38%) HIV+ versus 113 (26%) HIV- individuals showed CI: (P < 0.001). We found significant effects of literacy [odds ratio (OR): 0.3; 95% CI: 0.2 to 0.4; P < 0.001] and World Health Organization stage 4 (OR: 1.5; 95% CI: 1.0 to 2.q; P = 0.046) on CI. Tanzanians (OR: 3.2; 95% CI: 2.4 to 4.3; P < 0.001) and Kenyans (OR: 2.0; 95% CI: 1.6 to 2.6; P < 0.001) had higher risk of CI compared with Ugandans. Results were relatively unchanged in predictive models of NP-6, with the only difference being an additional significant effect of current CD4 cell count (coeff: 0.0; 95% CI: 0.0 to 0.0; P = 0.005).ConclusionsLiteracy, country, World Health Organization stage, and current CD4 cell count were associated with increased risk of cognitive dysfunction. Our findings help optimize care practices in Africa, illustrating the importance of strategies for early and effective viral-immunological control

Perinatal Depressive Symptoms and Viral Non-suppression Among a Prospective Cohort of Pregnant Women Living with HIV in Nigeria, Kenya, Uganda, and Tanzania

Depression is common during pregnancy and is associated with reduced adherence to HIV-related care, though little is known about perinatal trajectories of depression and viral suppression among women living with HIV (WLHV) in sub-Saharan Africa. We sought to assess any association between perinatal depressive symptoms and viral non-suppression among WLWH. Depressive symptomatology and viral load data were collected every 6 months from WLWH enrolled in the African Cohort Study (AFRICOS; January 2013-February 2020). Generalized estimating equations modeled associations between depressive symptoms [Center for Epidemiological Studies Depression (CES-D) ≥ 16] and viral non-suppression. Of 1722 WLWH, 248 (14.4%) had at least one pregnancy (291 total) and for 61 pregnancies (21.0%), women reported depressive symptoms (13.4% pre-conception, 7.6% pregnancy, 5.5% one-year postpartum). Depressive symptomatology was associated with increased odds of viral non-suppression (aOR 2.2; 95% CI 1.2-4.0, p = 0.011). Identification and treatment of depression among women with HIV may improve HIV outcomes for mothers