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PloS One 2024Pre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in preventing HIV infection. Female Bar Workers (FBWs) often act as informal sex workers, placing them at risk... (Randomized Controlled Trial)
Randomized Controlled Trial
Demonstrating service delivery models for effective initiation and retention on pre-exposure prophylaxis (PrEP) among female bar workers in Dar es Salaam, Tanzania: A double randomized intervention study protocol.
BACKGROUND
Pre-Exposure Prophylaxis (PrEP) has demonstrated efficacy in preventing HIV infection. Female Bar Workers (FBWs) often act as informal sex workers, placing them at risk of HIV infection. Despite expressing interest in PrEP, FBWs face barriers to accessing public-sector clinics where PrEP is delivered. We developed a study to compare the effectiveness of workplace-based PrEP provision to standard-of-care facility-based provision for PrEP initiation, retention and adherence among FBWs.
METHODS
In this double-randomized intervention study, FBWs aged 15 years and above will be screened, consented and initiated on PrEP (emtricitabine/tenofovir disoproxil), and followed for six months. Participants will be randomized at the bar level and offered PrEP at their workplace or at a health facility. Those who are initiated will be independently individually randomized to either receive or not receive an omni-channel PrEP champion intervention (support from an experienced PrEP user) to improve PrEP adherence. We expect to screen 1,205 FBWs to enroll at least 160 HIV negative women in the study. Follow-up visits will be scheduled monthly. HIV testing will be performed at baseline, month 1, 4 and 6; and TDF testing at months 2 and 6. Primary outcomes for this trial are: (1) initiation on PrEP (proportion of those offered PrEP directly observed to initiate PrEP); and (2) adherence to PrEP (detectable urine TDF drug level at 6-months post-enrollment). The primary outcomes will be analyzed using Intention-to-Treat (ITT) analyses.
DISCUSSION
Using a randomized trial design, we will evaluate two interventions aiming to reduce barriers to uptake and retention on PrEP among FBWs, a vulnerable population at risk of HIV acquisition and onward transmission. If these interventions prove effective in promoting PrEP among FBWs, they could assist in abating the HIV epidemic in Africa.
TRIAL REGISTRATION
Registered with German Clinical Trials Register (www.drks.de) on 29 April 2020; Registration number DRKS00018101.
Topics: Humans; Female; Pre-Exposure Prophylaxis; HIV Infections; Tanzania; Anti-HIV Agents; Sex Workers; Adult; Medication Adherence; Adolescent; Young Adult; Tenofovir
PubMed: 38935796
DOI: 10.1371/journal.pone.0304077 -
PloS One 2024The HIV program in Newfoundland and Labrador (NL) provides care for all persons living with HIV (PLWH) in NL, yet progress toward UNAIDS 95-95-95 goals for diagnosis,...
The HIV program in Newfoundland and Labrador (NL) provides care for all persons living with HIV (PLWH) in NL, yet progress toward UNAIDS 95-95-95 goals for diagnosis, linkage to care and viral suppression has not previously been documented. This analysis describes engagement in HIV care and virologic outcomes for the NL cohort in 2016 and 2019 and compares this data to the Canadian HIV Observational Cohort (CANOC). A retrospective review of the NL clinic included adults aged >18 years and descriptive statistics for demographics, risk factors, and clinical variables were assessed and compared using χ2 test or Fisher's Exact test (categorical) or Wilcoxon Sum Rank test (continuous). Engagement in care and virologic outcomes for the NL cohort were consistently high over the 2016 to 2019 period with > 98% on antiretroviral therapy (ART), and > 96% having a suppressed virus load. Engagement in care and virologic outcomes among PLWH in NL is high and compares favorably to a national cohort.
Topics: Humans; HIV Infections; Newfoundland and Labrador; Female; Male; Adult; Retrospective Studies; Middle Aged; World Health Organization; Viral Load; Anti-HIV Agents
PubMed: 38935671
DOI: 10.1371/journal.pone.0305898 -
Indian Journal of Public Health Oct 2023Pattern of physical growth and pubertal changes among 59 girls, aged 8-15 years, diagnosed as cases of HIV on anti-retroviral therapy was cross-sectionally studied....
Pattern of physical growth and pubertal changes among 59 girls, aged 8-15 years, diagnosed as cases of HIV on anti-retroviral therapy was cross-sectionally studied. Besides, measurement of body weight, height, and body mass index, breast development stage, presence or absence of pubic and axillary hair, and age of attainment of menarche were also noted in these subjects in the growth clinic of the department. With the advancement of age, the weight and height of HIV girls increased; however, they were lighter and shorter compared to their normal peers. 15.3% of HIV girls were short-statured and underweight. None of the study participants were found to be overweight or obese. 40.7% of HIV girls had attained menarche (mean age: 12.58 ± 1.349 years). The appearance of pubic (13.45 ± 1.64 years) and axillary hair (13.73 ± 1.41 years) occurred around 1 year later. The delayed physical growth and puberty attainment of HIV girls than their normal counterparts may be due to the influence of the disease.
Topics: Humans; Female; Adolescent; Child; HIV Infections; Cross-Sectional Studies; Puberty; Body Mass Index; Menarche; Body Height; India; Body Weight; Child Development
PubMed: 38934819
DOI: 10.4103/ijph.ijph_1651_22 -
Virulence Dec 2024The implementation of pretreatment drug-resistance (PDR) surveillance among people living with HIV-1 (PLWH) is a top priority in countries using efavirenz...
The implementation of pretreatment drug-resistance (PDR) surveillance among people living with HIV-1 (PLWH) is a top priority in countries using efavirenz (EFV)/nevirapine (NVP) for first-line ART. In this study, we assessed the prevalence of PDR among PLWH in Shanghai, China during 2017-2021, and to reveal PDR transmission between Shanghai and other regions of China. A total of 5050 PLWH not on ART during 2017-2021 were included. Partial HIV-1 sequences were amplified, sequenced, and analysed for drug-resistance mutations (DRMs). Besides, transmission network of PDR variants was inferred using HIV-TRACE. The overall prevalence of PDR was 4.8% (242/5050; 95% CI, 4.2-5.4). Prevalence of NNRTI-associated PDR was 3.9% (95% CI, 3.4-4.5), higher than those of NRTI-associated (0.8%; 95% CI, 0.5-1.1) and PI-associated PDR (0.9%; 95% CI, 0.6-1.2). High prevalence of PDR (especially high-level resistance) to EFV (132/5050, 2.6%) and NVP (137/5050, 2.7%) were found. CRF01_AE (46.0%) was the predominant HIV-1 genotype with any DRMs, followed by CRF55_01B (21.0%), and CRF07_BC (15.1%). Two NRTI-associated (S68G/N/R and T215A/N/S/Y), five NNRTI-associated (V179D/E/T/L, K103N/R/S/T, E138A/G/K, V106M/I/A and Y181C/I) and two PI-associated mutations (M46I/L/V and Q58E) were the most common observed DRMs in PDR patients in Shanghai. The vast majority of S68G occurred in CRF01_AE (45%). M46I/L/V and Q58E showed a relatively high prevalence in CRF01_AE (4.1%) and CRF07_BC (12.6%). Transmission network analyses demonstrated cross-regional transmission links of PDR variants between Shanghai and other regions of China, which was mainly driven by the potential low-level DRM V179D/E. These results provide crucial information for clinical decision making of first-line ART in PLWH with PDR.
Topics: Humans; China; HIV-1; HIV Infections; Male; Drug Resistance, Viral; Female; Prevalence; Adult; Middle Aged; Anti-HIV Agents; Mutation; Young Adult; Cyclopropanes; Alkynes; Benzoxazines; Adolescent; Genotype; Nevirapine; Aged
PubMed: 38934465
DOI: 10.1080/21505594.2024.2373105 -
Bulletin of the World Health... Jul 2024To explore the feasibility of building a primary care performance dashboard using DHIS2 data from Ethiopia's largest urban (Addis Ababa), agrarian (Oromia) and pastoral...
OBJECTIVE
To explore the feasibility of building a primary care performance dashboard using DHIS2 data from Ethiopia's largest urban (Addis Ababa), agrarian (Oromia) and pastoral (Somali) regions.
METHODS
We extracted 26 data elements reported by 12 062 health facilities to DHIS2 for the period 1 July 2022 to 30 June 2023. Focusing on indicators of effectiveness, safety and user experience, we built 14 indicators of primary care performance covering reproductive, maternal and child health, human immunodeficiency virus, tuberculosis, noncommunicable disease care and antibiotic prescription. We assessed data completeness by calculating the proportion of facilities reporting each month, and examined the presence of extreme outliers and assessed external validity.
FINDINGS
At the regional level, average completeness across all data elements was highest in Addis Ababa (82.9%), followed by Oromia (66.2%) and Somali (52.6%). Private clinics across regions had low completeness, ranging from 38.6% in Somali to 58.7% in Addis Ababa. We found only a few outliers (334 of 816 578 observations) and noted that external validity was high for 11 of 14 indicators of primary care performance. However, the 12-month antiretroviral treatment retention rate and proportions of patients with controlled diabetes or hypertension exhibited poor external validity.
CONCLUSION
The Ethiopian DHIS2 contains information for measuring primary care performance, using simple analytical methods, at national and regional levels and by facility type. Despite remaining data quality issues, the health management information system is an important data source for generating health system performance assessment measures on a national scale.
Topics: Ethiopia; Primary Health Care; Humans; Quality Indicators, Health Care; HIV Infections
PubMed: 38933476
DOI: 10.2471/BLT.23.291122 -
The Pan African Medical Journal 2024tuberculosis (TB) and Human Immunodeficiency Virus (HIV) remain major public health threats globally and worse when they co-exist in susceptible individuals. The study...
INTRODUCTION
tuberculosis (TB) and Human Immunodeficiency Virus (HIV) remain major public health threats globally and worse when they co-exist in susceptible individuals. The study examined TB treatment outcomes and their predictive factors among people living with HIV (PLHIVs).
METHODS
a review of TB/HIV co-infected patients who had TB treatments across comprehensive antiretroviral therapy (ART) sites with ≥500 patients was conducted in seven United States of America President's Emergency Plan for AIDS Relief (PEPFAR)-supported States in Nigeria. Data on patient background, HIV and TB care, and TB treatment outcomes were collected using an Excel abstraction template. The data was analyzed using SPSS and an association was examined using a chi-square test while binary logistic regression was used to determine predictors of TB treatment outcomes (P< 0.05).
RESULTS
two thousand six hundred and fifty-two co-infected patients participated in the study. The mean age of participants was 37 ± 14 years. A majority had TB treatment success (cured = 1059 (39.9%), completed = 1186 (44.7%)). Participants who had pulmonary TB, virally suppressed and commenced isoniazid (INH) before TB diagnosis were more likely to have a favorable TB treatment outcome compared to those who had extrapulmonary TB (AOR = 7.110, 95% CI = 1.506 - 33.565), virally unsuppressed (AOR = 1.677, 95% CI = 1.036 - 2.716) or did not commence INH before TB diagnosis (AOR = 1.486, 95% CI = 1.047 - 2.109).
CONCLUSION
site of infection, immune status, exposure to ART, and INH prophylaxis were found to predict TB treatment outcomes among PLHIVs. Stakeholders should ensure early commencement of ART and INH prophylaxis for PLHIVs.
Topics: Humans; Nigeria; HIV Infections; Adult; Female; Antitubercular Agents; Male; Tuberculosis; Middle Aged; Coinfection; Treatment Outcome; Young Adult; Anti-HIV Agents; Isoniazid; Retrospective Studies; Tuberculosis, Pulmonary
PubMed: 38933432
DOI: 10.11604/pamj.2024.47.149.35719 -
AIDS (London, England) Jul 2024Twenty-eight individuals who experienced proximal renal tubulopathy (PRT, Fanconi syndrome) while receiving tenofovir disoproxil initiated tenofovir alafenamide (TAF)...
Twenty-eight individuals who experienced proximal renal tubulopathy (PRT, Fanconi syndrome) while receiving tenofovir disoproxil initiated tenofovir alafenamide (TAF) and were followed for 5 years. None developed recurrent PRT or experienced significant changes in estimated glomerular filtration rate (by creatinine or cystatin-C), albuminuria, proteinuria, retinol-binding proteinuria, fractional excretion of phosphate, alkaline phosphatase, or bone mineral density at the lumbar spine. These data suggest that TAF is a well tolerated treatment option for individuals vulnerable to developing PRT.
Topics: Humans; Tenofovir; Alanine; Male; Anti-HIV Agents; HIV Infections; Adenine; Female; Fanconi Syndrome; Adult; Middle Aged
PubMed: 38932750
DOI: 10.1097/QAD.0000000000003916 -
AIDS (London, England) Jul 2024Women living with HIV and breast cancer have poorer survival than HIV-negative women. Efavirenz-estrogen interactions are documented; however, the survival impact is...
Women living with HIV and breast cancer have poorer survival than HIV-negative women. Efavirenz-estrogen interactions are documented; however, the survival impact is unknown. Survival between women with estrogen-receptor positive breast cancer taking efavirenz (n = 38) and nonefavirenz regimens (n = 51) were compared. The 5-year overall-survival was 48.9% [95% confidence interval (CI) 33.0-72.2 and 51.1% (95% CI 34.0-76.8)] in the efavirenz and nonefavirenz groups, respectively suggesting efavirenz is unlikely driving poorer survival in women living with HIV and estrogen-receptor positive breast cancer.
Topics: Humans; Benzoxazines; Cyclopropanes; Female; Alkynes; Breast Neoplasms; HIV Infections; Middle Aged; Adult; Anti-HIV Agents; Survival Analysis; Aged
PubMed: 38932749
DOI: 10.1097/QAD.0000000000003912 -
AIDS (London, England) Jul 2024
Topics: Humans; Female; Pregnancy; Pyridones; HIV Infections; Pregnancy Complications, Infectious; Tenofovir; Anti-HIV Agents; Oxazines; Heterocyclic Compounds, 3-Ring; Lamivudine; Piperazines; Treatment Outcome
PubMed: 38932745
DOI: 10.1097/QAD.0000000000003911 -
Vaccines Jun 2024Immunosuppressed individuals, such as people living with HIV (PLWH), remain vulnerable to severe COVID-19. We analyzed the persistence of specific SARS-CoV-2 humoral and...
Immunosuppressed individuals, such as people living with HIV (PLWH), remain vulnerable to severe COVID-19. We analyzed the persistence of specific SARS-CoV-2 humoral and cellular immune responses in a retrospective, cross-sectional study in PLWH on antiretroviral therapy. Among 104 participants, 70.2% had anti-S IgG antibodies, and 55.8% had significant neutralizing activity against the Omicron variant in a surrogate virus neutralization test. Only 38.5% were vaccinated (8.76 ± 4.1 months prior), all displaying anti-S IgG, 75% with neutralizing antibodies and anti-S IgA. Overall, 29.8% of PLWH had no SARS-CoV-2 serologic markers; they displayed significantly lower CD4 counts and higher HIV viral load. Severe immunosuppression (present in 12.5% of participants) was linked to lower levels of detectable anti-S IgG ( = 0.0003), anti-S IgA ( < 0.0001) and lack of neutralizing activity against the Omicron variant ( < 0.0001). T-cell responses were present in 86.7% of tested participants, even in those lacking serological markers. In PLWH without severe immunosuppression, neutralizing antibodies and T-cell responses persisted for up to 9 months post-infection or vaccination. Advanced immunosuppression led to diminished humoral immune responses but retained specific cellular immunity.
PubMed: 38932392
DOI: 10.3390/vaccines12060663