HIV self-test performance evaluation among priority populations in rural Mozambique: Results from a community-based observational study.

BACKGROUND: In 2021, Mozambique initiated community-based oral HIV self-testing (HIVST) to increase testing access and uptake among priority groups, including adult males, adolescents, and young adults. Within an HIVST pilot project, we conducted a performance evaluation assessing participants' ability to successfully conduct HIVST procedures and interpret results. METHODS: A cross-sectional study was performed between February-March 2021 among employees, students (18-24 years of age), and community members, using convenience sampling, in two rural districts of Zambézia Province, Mozambique. We quantified how well untrained users performed procedures for the oral HIVST (Oraquick®) through direct observation using a structured checklist, from which we calculated an HIVST usability index (scores ranging 0-100%). Additionally, participants interpreted three previously processed anonymous HIVST results. False reactive and false non-reactive interpretation results were presented as proportions. Bivariate analysis was conducted using Chi-square and Fisher exact tests. RESULTS: A total of 312 persons participated (131[42%] community members, 71[23%] students, 110[35%] employees); 239 (77%) were male; the mean age was 28 years (standard deviation 10). Average usability index scores were 80% among employees, 86% among students, and 77% among community members. Main procedural errors observed included "incorrect tube positioning" (49%), "incorrect specimen collection" (43%), and "improper waiting time for result interpretation" (42%). From the presented anonymous HIVST results, 75% (n = 234) correctly interpreted all three results, while 9 (3%) of study participants failed to correctly interpret any results. Overall, 36 (12%) gave a false non-reactive result interpretation, 21 (7%) a false reactive result interpretation, and 14 (4%) gave both false non-reactive and false reactive result interpretations. Community members generally had lower performance. CONCLUSIONS: Despite some observed testing procedural errors, most users could successfully perform an HIVST. Educational sessions at strategic places (e.g., schools, workplaces), and support via social media and hotlines, may improve HIVST performance quality, reducing the risk of incorrect interpretation.

Sickle cell trait, APOL1 risk allele status and chronic kidney disease among ART-experienced adults living with HIV in northern Nigeria.

BACKGROUND: We sought to determine the prevalence of sickle cell trait (SCT) and apolipoprotein-1 (APOL1) risk variants in people living with HIV (PLWH) in Nigeria, and to establish if SCT and APOL1 high-risk status correlate with estimated glomerular filtration rate (eGFR) and/or prevalent chronic kidney disease (CKD). METHODS: Baseline demographic and clinical data were obtained during three cross-sectional visits. CKD was defined as having an eGFR<60 mL/min/1.73 m2. We collected urine specimens to determine urine albumin-creatine ratio and blood samples for sickle cell genotyping, APOL1 testing, and for creatinine/cystatin C assessment. The associations between SCT, APOL1 genotype, and eGFR/CKD stages/CKD were investigated using linear/ordinal logistic/logistic regression models, respectively. RESULTS: Of 2443 participants, 599 (24.5%) had SCT, and 2291 (93.8%) had a low-risk APOL1 genotype (0 or 1 risk variant), while 152 (6.2%) had high-risk genotype (2 allele copies). In total, 108 participants (4.4%) were diagnosed with CKD. In adjusted analyses, SCT was associated with lower eGFR (adjusted mean difference [aMD]= -2.33, 95% CI -4.25, -0.42), but not with worse CKD stages, or increased odds of developing CKD. Participants with the APOL1 high risk genotype were more likely to have lower eGFR (aMD= -5.45, 95% CI -8.87, -2.03), to develop CKD (adjusted odds ratio [aOR] = 1.97, 95% CI: 1.03, 3.75), and to be in worse CKD stages (aOR = 1.60, 95% CI: 1.12, 2.29) than those with the low-risk genotype. There was no evidence of interaction between SCT and APOL1 genotype on eGFR or risk of CKD. CONCLUSION: Our findings highlight the multifaceted interplay of genetic factors in the pathogenesis of CKD in PLWH.

Factors Associated with Utilization of Sexual and Reproductive Health Services among Married Adolescent Girls in Kano, Northern Nigeria.

Background and Objective: Married adolescents face significant obstacles in making informed reproductive health decisions and accessing sexual and reproductive health (SRH) services. It is important to identify barriers hindering these adolescents from accessing SRH services. The aim of this study was to identify factors associated with the utilization of SRH services among married adolescent girls in northern Nigeria. Methods: We used a cross-sectional study design. The study population comprised of married female adolescents aged 14-19 years who were residents in the study areas for at least six months. The outcome measure was SRH service utilization, defined as the use of any of the conventional SRH services (ante/postnatal care, human immunodeficiency virus (HIV) testing and counseling, sexually transmitted infections (STI) treatment, family planning, and post-abortion care). Predictor variables included the sociodemographic, obstetric, and gynecological characteristics of the respondents. An adapted, pretested, interviewer-administered, and semi-structured questionnaire was employed for data collection. Multivariable logistic regression was used to explore the independent association between selected variables and utilization of SRH services. Results: A total of 200 respondents were surveyed (100 each from an urban and a rural community in Kano, Nigeria), survey response rate: 94.5%. The age of respondents ranged from 14 to 19 years, with mean age (± standard deviation) of 18.5 (±1.1) years and 17.5 (±1.3) years for urban and rural respondents, respectively. All respondents were aware of the available SRH facilities and preferred public facilities (92.6% urban respondents and 67.0% rural respondents). Ever-use of SRH services was higher among urban than rural respondents (86% vs. 56%, respectively). Geographic proximity was a key factor for urban respondents (64.2%), while affordability was considered important by rural respondents (47.9%). Respondent's age and partner's occupation were independently associated with utilization of SRH services. Urban respondents whose husbands were businessmen were seven times more likely to use SRH services than those whose partners were civil servants (adjusted odds ratio [aOR] = 6.80, 95% confidence interval [CI]: 1.29-35.84, P = 0.02). Rural respondents 18 years of age and older were approximately six times more likely to utilize SRH services than those <18 years (aOR = 5.71, 95% CI: 1.56-12.78, P = 0.01). Conclusion and Global Health Implications: Awareness of available SRH services was high in the study population, and service utilization was influenced by the respondent's age and partner's occupation. Findings from this study can help inform the development of age-appropriate and accessible SRH services tailored to married adolescents in similar settings.

Establishing Reference Intervals for Serum and Salivary Cortisol in a Selected Population in Kano, Nigeria.

OBJECTIVE: Serum cortisol has long been used in the assessment of disorders of the hypothalamic-pituitary-adrenal axis. The reference interval for cortisol in both serum and saliva depends on the analytical methodology and the population studied; hence, a locally derived population-based reference interval is recommended. To our knowledge, there are no studies on reference interval determination in the study area, raising concerns about the use of reference intervals established in European and North American populations. This work aimed to establish reference intervals for baseline serum and salivary cortisol levels among healthy adults in Kano, Nigeria, using methods available in our laboratory. METHODS: A cross-section of 148 apparently healthy reference individuals aged 16 to 67 years were recruited from a local community in Kano, Nigeria, using a systematic sampling technique. Baseline serum cortisol was analyzed using highly sensitive and specific electrochemiluminescence quantitative measurements on an automated immunology analyzer. Salivary cortisol levels were measured using Salimetrics' competitive enzyme-linked immunosorbent assay test kits. Parametric methods with a 95% confidence interval were used to calculate reference intervals. RESULTS: The reference intervals for cortisol in serum and saliva were 72.0 nmo/L to 554.0 nmol/L and 0.40 nmol/L to 18.0 nmol/L, respectively. There was a weak positive correlation between serum and salivary cortisol values, but this association was not statistically significant. CONCLUSION: The development of locally derived adult reference intervals can improve the diagnostic utility of serum and salivary cortisol assessment and strengthen the reliability of adrenal insufficiency diagnoses in our population.

Time spent at health facility is a key driver of patient satisfaction, but did not influence retention to HIV care: A serial cross-sectional study in Mozambique.

INTRODUCTION: Patient satisfaction with clinical services can have an effect on retention in HIV care and adherence to antiretroviral therapy. This study assessed patient satisfaction and its association with retention and viral suppression in Zambézia Province, Mozambique. METHODS: Monthly exit interviews with persons living with HIV were completed from August 2017-January 2019 in 20 health facilities; clinical data were extracted from medical records. Regression analyses assessed the effect of satisfaction scores on retention and viral suppression, adjusting for age, sex, education, civil status, time on treatment, and site. Satisfaction scores were correlated with time spent at health facilities using generalized linear regression models. RESULTS: Data from 4388 patients were analyzed. Overall median satisfaction score was 75% (IQR 53%-84%); median time spent at facilities (from arrival until completion of clinical services) was 2h54min (IQR 1h48min-4h). Overall satisfaction score was not associated with higher odds of retention or viral suppression, but association was seen between satisfaction regarding attention given to patient and respect and higher odds of viral suppression. Patient satisfaction was negatively associated with time spent in facility (Spearman's correlation -0.63). Increased time spent at facility (from 1 to 3 hours) was not associated with lower retention in care (OR 0.72 [95%CI:0.52-1.01] and 0.83 [95%CI: 0.63-1.09] at 6- and 12-months, respectively), nor with a lower odds of viral suppression (OR 0.96 [95%CI: 0.71-1.32]). CONCLUSIONS: Strategies to reduce patient wait times at the health facility warrant continued prioritization. Differentiated models of care have helped considerably, but novel approaches are still needed to further decongest crowded health facilities. In addition, a good client-provider communication and positive attitude can improve patient satisfaction with health services, with an overall improved retention.

The V-BRCH Project: Strengthening HIV Research Capacity in Nigeria through Intensive Workshops in Implementation Science and Grant Writing.

As persons with HIV live longer as the result of antiretroviral therapy, morbidity from HIV-associated noncommunicable diseases (NCDs) is increasing. The Vanderbilt-Nigeria Building Research Capacity in HIV and Noncommunicable Diseases program is a training platform created with the goal of training a cohort of successful Nigerian investigators to become leaders in HIV-associated NCD research. We describe survey findings from two week-long workshops in Kano, Nigeria, where trainees received instruction in implementation science and grant writing. Surveys assessed participants' self-perceived knowledge and confidence in topics taught during these workshops. Thirty-seven participants (all assistant professors) attended the implementation science workshop; 30 attended the grant-writing workshop. Response rates for the implementation science workshop were 89.2% for the preworkshop survey and 91.9% for the postworkshop survey. For the grant-writing workshop, these values were 88.2% and 85.3%, respectively. Improvement in participant knowledge and confidence was observed in every domain measured for both workshops. On average, a 101.4% increase in knowledge and a 118.0% increase in confidence was observed across measured domains among participants in the implementation science workshop. For the grant-writing workshop, there was a 68.8% increase in knowledge and a 70.3% increase in confidence observed. Participants rated the workshops and instructors as effective for both workshops. These workshops improved participants' knowledge and competence in implementation science and grant writing, and provide a model for training programs that aim to provide physician scientists with the skills needed to compete for independent funding, conduct locally relevant research, and disseminate research findings.

Availability of substance use screening and treatment within HIV clinical sites across seven geographic regions within the IeDEA consortium.

BACKGROUND: Overwhelming evidence highlights the negative impact of substance use on HIV care and treatment outcomes. Yet, the extent to which alcohol use disorder (AUD) and other substance use disorders (SUD) services have been integrated within HIV clinical settings is limited. We describe AUD/SUD screening and treatment availability in HIV clinical sites participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. METHODS: In 2020, 223 IeDEA HIV clinical sites from 41 countries across seven geographic regions completed a survey on capacity and practices related to management of AUD/ SUD. Sites provided information on AUD and other SUD screening and treatment practices. RESULTS: Sites were from low-income countries (23%), lower-middle-income countries (38%), upper-middle income countries (17%) and high-income counties (23%). AUD and SUD screening using validated instruments were reported at 32% (n=71 located in 12 countries) and 12% (n=27 located in 6 countries) of the 223 sites from 41 countries, respectively. The North American region had the highest proportion of clinics that reported AUD screening (76%), followed by East Africa (46%); none of the sites in West or Central Africa reported AUD screening. 31% (n=69) reported both AUD screening and counseling, brief intervention, psychotherapy, or Screening, Brief Intervention, and Referral to Treatment; 8% (n=18) reported AUD screening and detox hospitalization; and 10% (n=24) reported both AUD screening and medication. While the proportion of clinics providing treatment for SUD was lower than those treating AUD, the prevalence estimates of treatment availability were similar. CONCLUSIONS: Availability of screening and treatment for AUD/SUD in HIV care settings is limited, leaving a substantial gap for integration into ongoing HIV care. A critical understanding is needed of the multilevel implementation factors or feasible implementation strategies for integrating screening and treatment of AUD/SUD into HIV care settings, particularly for resource-constrained regions.

HIV self-test performance evaluation among priority populations in rural Mozambique: Results from a community-based observational study

Background In 2021, Mozambique initiated community-based oral HIV self-testing (HIVST) to increase testing access and uptake among priority groups, including adult males, adolescents, and young adults. Within an HIVST pilot project, we conducted a performance evaluation assessing participants' ability to successfully conduct HIVST procedures and interpret results. Methods A cross-sectional study was performed between February-March 2021 among employees, students (18­24 years of age), and community members, using convenience sampling, in two rural districts of Zambézia Province, Mozambique. We quantified how well untrained users performed procedures for the oral HIVST (Oraquick®) through direct observation using a structured checklist, from which we calculated an HIVST usability index (scores ranging 0­100%). Additionally, participants interpreted three previously processed anonymous HIVST results. False reactive and false non-reactive interpretation results were presented as proportions. Bivariate analysis was conducted using Chi-square and Fisher exact tests. Results A total of 312 persons participated (131[42%] community members, 71[23%] students, 110[35%] employees); 239 (77%) were male; the mean age was 28 years (standard deviation 10). Average usability index scores were 80% among employees, 86% among students, and 77% among community members. Main procedural errors observed included "incorrect tube positioning" (49%), "incorrect specimen collection" (43%), and "improper waiting time for result interpretation" (42%). From the presented anonymous HIVST results, 75% (n = 234) correctly interpreted all three results, while 9 (3%) of study participants failed to correctly interpret any results. Overall, 36 (12%) gave a false non-reactive result interpretation, 21 (7%) a false reactive result interpretation, and 14 (4%) gave both false non-reactive and false reactive result interpretations. Community members generally had lower performance. Conclusions Despite some observed testing procedural errors, most users could successfully perform an HIVST. Educational sessions at strategic places (e.g., schools, workplaces), and support via social media and hotlines, may improve HIVST performance quality, reducing the risk of incorrect interpretation.

Training the next generation of Biostatisticians in West Africa: The Vanderbilt Nigeria Biostatistics Training Program (VN-BioStat).

Biomedical HIV research is growing in West Africa, but biostatistical expertise is lagging. The Vanderbilt-Nigeria Biostatistics Training Program (VN-BioStat) seeks to establish a research and training platform for biostatisticians doing HIV-related research in Nigeria. The objectives of the program are: 1) Host two Nigerian data scientists per year (a total of 10 over 5 years) at Vanderbilt University Medical Center to gain hands-on biostatistics training and experience via one-year fellowships. Eligible trainees will be junior investigators with PhDs or nearing completion of their PhDs in statistics or related fields, including mathematics and computer science. 2) Conduct annual workshops in Nigeria to provide biostatistics training. Trainees will undertake biostatistics coursework and hands-on training and participate in mentorship as biostatisticians involved in HIV research. Trainees will be at Vanderbilt for a full year and be part of an active biostatistics department. They will be immersed in a dry-lab HIV biostatistics project in collaboration with a Nigerian HIV research project and lead a methodologically focused research project. They will also participate in a one-month research training/grant writing program in Nashville. The VN-BioStat program will build on the existing momentum of ongoing initiatives to enhance research capacity in Nigeria by developing biostatistics leadership. VN-BioStat trainees will interact with investigators from Nigeria to provide collaborative biostatistical assistance with study design and data analysis, thus gaining real-world experience that will benefit the trainees and the broader research community in Nigeria.

Favorable Impact of Community Adherence Support Groups on Retention in Care and Viral Suppression Rates Among Persons with HIV Receiving Antiretroviral Therapy in Mozambique

The community adherence support group (CASG) was one of the first differentiated service delivery (DSD) models introduced in Mozambique. This study assessed the impact of this model on retention in care, loss to follow-up (LTFU), and viral suppression among antiretroviral therapy (ART)-treated adults in Mozambique. A retrospective cohort study included CASG-eligible adults enrolled between April 2012 and October 2017 at 123 health facilities in Zambézia Province. Propensity score matching (1:1 ratio) was used to allocate CASG members and those who never enrolled in a CASG. Logistic regressions were performed to estimate the impact of CASG membership on 6- and 12-month retention and viral load (VL) suppression. Cox proportional regression was used to model differences in LTFU. Data from 26,858 patients were included. The median age at CASG eligibility was 32 years and 75% were female, with 84% residing in rural areas. A total of 93% and 90% of CASG members were retained in care at 6 and 12 months, respectively, while 77% and 66% non-CASG members were retained during the same periods. The odds of being retained in care at 6 and 12 months were significantly higher among patients receiving ART through CASG support (adjusted odds ratio [aOR] = 4.19 [95% confidence interval; CI: 3.79-4.63], p < .001, and aOR = 4.43 [95% CI: 4.01-4.90], p < .001, respectively). Among 7,674 patients with available VL measurements, the odds of being virally suppressed were higher among CASG members (aOR = 1.14 [95% CI: 1.02-1.28], p < .001). Non-CASG members had a significantly higher likelihood of being LTFU (adjusted hazard ratio = 3.45 [95% CI: 3.20-3.73], p < .001). While Mozambique rapidly scales up multi-month drug dispensation as the preferred DSD model, this study emphasizes the continued importance of CASG as an efficacious DSD alternative, especially among patients residing in rural areas, where CASG acceptability is higher.

The Vanderbilt Nigeria Biostatistics Training Program (VN-BioStat): Results from a Skills Workshop.

The Vanderbilt-Nigeria Biostatistics Training Program (VN-BioStat) aims to establish a research and training platform for biostatisticians doing HIV-related research in Nigeria, including enhancing mid-level biostatistics capacity through annual workshops. This paper describes findings from the inaugural workshop in Kano, Nigeria. Participants were surveyed before and after the workshop to assess their self-perceived familiarity with and confidence in their abilities to use statistical software and apply specific statistical techniques, as well as to gather feedback regarding the conduct of the workshop and future topic areas. Of the 23 participants enrolled in the workshop, 22 (96%) completed both pre- and post-workshop assessments. In both pre-workshop and post-workshop surveys, participants ranked their confidence in statistical skills using Likert scales. Scores were transformed to a 0-100 scale, and averages computed. Participants also shared open-ended feedback about the workshop and suggested future topic areas. Before the training, the average participant reported having either a "beginner" (30% of participants) or "moderate" (43%) level of familiarity with R. Many participants (65%) rated themselves as having "moderate" or "expert" familiarity with SPSS. Pre-workshop averages for confidence ranged from 26 to 64, with lowest confidence in "expanding continuous covariates in regression models and interpret results" and highest confidence in "fitting and interpreting results from a linear regression model". Post-workshop averages for confidence were all above 70. The lowest post-workshop score (74) was for "fit and interpret results from a semiparametric linear transformation model". The greatest increase in confidence was observed in "expanding continuous covariates in regression models using splines and interpreting results" and the lowest increase was in "fitting and interpreting results from a linear regression model." Participants offered positive feedback on instructor effectiveness (4.9/5) and overall course quality (4.9/5). While the overall course was rated on a 0-100 scale as "moderately difficult" (mean ± SD: 40.5 ± 17.5), the participants felt the course was highly organized (87.7 ± 17.8), and the information was moderately easy to learn (81.9 ± 15.9). Suggestions for future workshops included providing supplementary resources for out-of-classroom learning and releasing codes in advance to enhance participants' preparation. Among suggestions for future workshop topics, 80% of respondents listed survival analysis. Lessons learned provide insight into how short-term training opportunities can be leveraged to build biostatistics capacity in similar settings.

The effect of a Mentor Mothers program on prevention of vertical transmission of HIV outcomes in Zambézia Province, Mozambique: a retrospective interrupted time series analysis

Introduction: Mentor Mothers (MM) provide peer support to pregnant and postpartum women living with HIV (PPWH) and their infants with perinatal HIV exposure (IPE) throughout the cascade of prevention of vertical transmission (PVT) services. MM were implemented in Zambézia Province, Mozambique starting in August 2017. This evaluation aimed to determine the effect of MM on PVT outcomes. Methods: A retrospective interrupted time series analysis was done using routinely collected aggregate data from 85 public health facilities providing HIV services in nine districts of Zambézia. All PPWH (and their IPE) who initiated antiretroviral therapy (ART) from August 2016 through April 2019 were included. Outcomes included the proportion per month per district of: PPWH retained in care 12 months after ART initiation, PPWH with viral suppression and IPE with HIV DNA PCR test positivity by 9 months of age. The effect of MM on outcomes was assessed using logistic regression. Results: The odds of 12-month retention increased 1.5% per month in the pre-MM period, compared to a monthly increase of 7.6% with-MM (35-61% pre-MM, 56-72% with-MM; p < 0.001). The odds of being virally suppressed decreased by 0.9% per month in the pre-MM period, compared to a monthly increase of 3.9% with-MM (49-85% pre-MM, 59-80% with-MM; p < 0.001). The odds of DNA PCR positivity by 9 months of age decreased 8.9% per month in the pre-MM period, compared to a monthly decrease of 0.4% with-MM (0-14% pre-MM, 4-10% with-MM; p < 0.001). The odds of DNA PCR uptake (the proportion of IPE who received DNA PCR testing) by 9 months of age were significantly higher in the with-MM period compared to the pre-MM period (48-100% pre-MM, 87-100% with-MM; p < 0.001). Conclusions: MM services were associated with improved retention in PVT services and higher viral suppression rates among PPWH. While there was ongoing but diminishing improvement in DNA PCR positivity rates among IPE following MM implementation, this might be explained by increased uptake of HIV testing among high-risk IPE who were previously not getting tested. Additional efforts are needed to further optimize PVT outcomes, and MM should be one part of a comprehensive strategy to address this critical need.

CD4 Trends with evolving treatment initiation policies among children living with HIV in zambézia province, mozambique, 2012-2018

Background: Historically, antiretroviral therapy (ART) initiation was based on CD4 criteria, but this has been replaced with "Test and Start" wherein all people living with HIV are offered ART. We describe the baseline immunologic status among children relative to evolving ART policies in Mozambique. Methods: This retrospective evaluation was performed using routinely collected data. Children living with HIV (CL aged 5-14 years) with CD4 data in the period of 2012-2018 were included. ART initiation "policy periods" corresponded to implementation of evolving guidelines: in period 1 (2012-2016), ART was recommended for CD4 <350 cells/mm3; during period 2 (2016-2017), the CD4 threshold increased to <500 cells/mm3; Test and Start was implemented in period 3 (2017-2018). We described temporal trends in the proportion of children with severe immunodeficiency (CD4 <200 cells/mm3) at enrollment and at ART initiation. Multivariable regression models were used to estimate associations with severe immunodeficiency. Results: The cohort included 1815 children with CD4 data at enrollment and 1922 at ART initiation. The proportion of children with severe immunodeficiency decreased over time: 20% at enrollment into care in period 1 vs. 16% in period 3 (P = 0.113) and 21% at ART initiation in period 1 vs. 15% in period 3 (P = 0.004). Children initiating ART in period 3 had lower odds of severe immunodeficiency at ART initiation compared with those in period 1 [adjusted odds ratio (aOR) = 0.67; 95% CI: 0.51 to 0.88]. Older age was associated with severe immunodeficiency at enrollment (aOR = 1.13; 95% CI: 1.06 to 1.20) and at ART initiation (aOR = 1.14; 95% CI: 1.08 to 1.21). Conclusions: The proportion of children with severe immunodeficiency at ART initiation decreased alongside more inclusive ART initiation guidelines. Earlier treatment of children living with HIV is imperative.