Adherence determination using urine-tenofovir point-of-care testing and pharmacy refill records: A cross-sectional study.

Pharmacy refill records (PRR), are an accessible strategy for estimating adherence in low- and middle-income countries (LMICs). However, the low-cost urine-tenofovir point-of-care test opens up the possibility of an objective metric of adherence that is scalable to LMICs. This study compared adherence to tenofovir-based regimens using urine-tenofovir point-of-care (POC) test with pharmacy refill records in a Nigerian population of HIV-positive persons. This was a cross-sectional study among 94 HIV-positive adults, which was conducted from June to August 2021, in a large outpatient clinic in Lagos, Nigeria. Adherence to pharmacy appointments was automatically calculated using a computerized pharmacy appointment system (FileMaker Pro™). Urine drops on the urine-tenofovir POC test strip developed 2 lines for a negative test (tenofovir absent) and one line for a positive test. Fisher's exact test was used to examine the association between pharmacy refill record and urine-tenofovir point-of-care test. Logistic regression was performed to predict viral suppression (<1000 copies/mL, based on WHO recommendations) using both methods of adherence determination. A Receiver Operating Characteristic (ROC) curve of the association between specificity and sensitivity was generated to evaluate the predictive value of adherence determined using pharmacy-refill record and urine-tenofovir point-of-care test in forecasting viral suppression. The statistical significance level was set at 0.05. Fisher's exact test showed no statistically significant difference in adherence using urine-tenofovir point-of-care test or pharmacy refill record. The logistic regression model showed that an increase in pharmacy-refill record of ≥ 95% was associated with viral suppression (P = .019). From the ROC curve, the sensitivity was same at 95.5% for both methods, but the specificity of the urine-tenofovir point-of-care test was greater (96.6% vs 95.5%) than pharmacy refill record (P = .837). Urine-tenofovir point-of-care test provided equivalent adherence data to pharmacy refill data.

Incidence of and socio-biologic risk factors for spontaneous preterm birth in HIV positive Nigerian women.

BACKGROUND: Recent studies have identified HIV as a leading contributor to preterm delivery and its associated morbidity and mortality. However little or no information exists in our sub-region on this subject. Identifying the factors associated with preterm delivery in HIV positive women in our country and sub-region will not only prevent mother to child transmission of HIV virus but will also reduce the morbidity and mortality associated with prematurity and low birth weight. This study was designed to determine the incidence and risk factors for preterm delivery in HIV positive Nigerians. METHOD: The required data for this retrospective study was extracted from the data base of a cohort study of the outcome of prevention of mother to child transmission at the Nigerian Institute of Medical Research, Lagos. Only data of women that met the eligibility of spontaneous delivery after 20 weeks of gestation were included. Ethical approval was obtained from the Institution's Ethical Review Board. RESULTS: 181 women out of the 1626 eligible for inclusion into the study had spontaneous preterm delivery (11.1%). The mean birth weight was 3.1 ± 0.4 kg, with 10.3% having LBW. Spontaneous preterm delivery was found to be significantly associated with unmarried status (cOR: 1.7;1.52-2.57), baseline CD4 count <200 cells/mm(3) (cOR: 1.8; 1.16-2.99), presence of opportunistic infection at delivery (cOR: 2.2;1.23-3.57), multiple pregnancy (cOR 10.4; 4.24 - 26.17), use of PI based triple ARV therapy (eOR 10.2; 5.52 - 18.8) in the first trimester (cOR 2.5; 1.77 - 3.52) on univariate analysis. However after multivariate analysis controlling for potential confounding variables including low birth weight, only multiple pregnancy (aOR: 8.6; CI: 6.73 - 12.9), presence of opportunistic infection at delivery (aOR: 1.9; CI: 1.1 - 5.7), and 1st trimester exposure to PI based triple therapy (aOR: 5.4; CI: 3.4 - 7.8) retained their significant association with preterm delivery. CONCLUSION: The spontaneous preterm delivery rate among our cohort was 11.1%. HIV positive women with multiple pregnancies, symptomatic HIV infection at delivery and first trimester fetal exposure to PI based triple therapy were found to be at risk of spontaneous preterm delivery. Early booking and non-use of PI based triple therapy in the first trimester will significantly reduce the risk of preterm delivery.

High Acceptability of Donating Hair and Other Biological Samples for Research Among People Living with HIV in an Outpatient Clinic in Lagos, Nigeria.

Willingness to donate hair samples is a rate-limiting step for assaying antiretroviral (ARV) concentrations in hair, an emerging technique for HIV prevention and treatment monitoring. We surveyed ethnically diverse Nigerians to determine their willingness to donate hair for biomedical research. A cross-sectional survey of people living with HIV on ARV therapy (ART) was conducted at the HIV clinic of Nigerian Institute of Medical Research, using systematic sampling. The researcher-administered questionnaire was designed to capture sociodemographic data, length of time on ART, and willingness to donate hair. Univariate analysis was performed on sociodemographic characteristics, and independent-samples t-test and chi-square tests were used for bivariate analysis. Multivariable logistic regression analysis was performed to assess factors associated with willingness to donate hair samples, with a significance level of 0.05. Of the 398 participants enrolled in the study, 258 (64.8%) were female, the average age was 40 years (±9.8), and the average time spent on ART was 7.3 years (±4.2). More than half (64.8%) of the respondents were willing to donate hair samples for biomedical research and they were 1.5 times more likely to donate hair than blood. For one-third of the participants, the anticipated benefit from the eventual research findings was the primary motivation to donate hair samples. Fear of use of hair for rituals was the most common stated reason for unwillingness to donate hair samples (21.2%). In an ethnically diverse, urban-based Nigerian study population, nearly two-thirds of the participants were willing to donate hair samples for biomedical research. These findings support the feasibility of hair sampling for future HIV clinical research conducted within Nigeria.

Foetal loss and enhanced fertility observed in mice treated with Zidovudine or Nevirapine.

BACKGROUND: Health concerns for HIV-infected persons on antiretroviral therapy (ART) have moved from morbidity to the challenges of long-term ART. We investigated the effect of Zidovudine or Nevirapine on reproductive capacity across two mouse generations. METHODS: A prospective mouse study with drugs administered through one spermatogenic cycle. Mouse groups (16 males and 10 females) were given Zidovudine or Nevirapine for 56 days. Males were mated to untreated virgin females to determine dominant lethal effects. Twenty females (10 treated and 10 untreated) mated with the treated males per dose and gave birth to the F1 generation. Parental mice were withdrawn from drugs for one spermatogenic cycle and mated to the same dams to ascertain if effects are reversible. The F1 generation were exposed for another 56 days and mated to produce the F2 generation. RESULTS: Foetal loss was indicated in the dominant lethal assay as early as four weeks into drug administration to the males. At the first mating of the parental generation to produce the F1 generation, births from 10 dams/dose when the 'father-only' was exposed to Zidovudine (10, 100 and 250 mg/kg) was 3, 2 and 1 while it was 7, 1 and 4 respectively when 'both-parents' were exposed. Similarly births from the parental generation first mating when the 'father-only' was exposed to Nevirapine (5, 50 and 150 mg/kg) was 2, 2 and 0 while it was 6, 5 and 9 respectively when 'both-parents' were exposed. However, fertility was not significantly different neither by dose nor by the parental exposure. The F1 mice mated to produce the F2 generation recorded only one birth. CONCLUSION: The dominant lethal analysis showed foetal loss occurred when the "fathers-only" were treated while fertility was enhanced when "both-parents" were on therapy at the time of mating.