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Background: Few studies in sub-Saharan Africa have assessed the impact of multimonth dispensing (MMD) of antiretroviral therapy (ART) and dolutegravir (DTG) beyond clinical trials among children with HIV (CWHIV). We assessed the effect of the 2 interventions on achieving undetectable viral load (VL) among CWHIV in the age group of 0-15 years in Nigeria., Methods: We used longitudinal routine records and cross-sectional survey data from caregivers of a subsample of children. VLs were considered suppressed at <1000 copies/mL and undetectable at <50 copies/mL. Multimonth dispensing (MMD) was defined as ART refill for >84 days. The effect of MMD and DTG on VL levels and associations between social factors and VL were estimated using generalized linear models, reporting adjusted relative risks/prevalence ratios and 95% confidence intervals (CIs)., Results: Of 2490 CWHIV, 52% were male, with a median age of 10 years (interquartile ranges: 6-13) and a median duration on ART of 4.6 years (interquartile ranges: 2.8-7.1). Overall, 73% were on DTG and 55% received MMD. At baseline, 63% were suppressed, while 79% and 56% were suppressed and undetectable in their last VL, respectively. We found no differences in undetectable VL between those on MMD and not on MMD (adjusted relative risks: 1.05 [95% CI: 0.94-1.18]) and between those on DTG and not on DTG (1.07 [0.92-1.25]). In secondary analyses, poor adherence and being in a support group were associated with a lower likelihood of undetectable VL (adjusted prevalence ratios: 0.85 [95% CI: 0.74-0.96] and 0.81 [0.68-0.96], respectively)., Conclusion: MMD did not compromise treatment outcomes for CWHIV. Poor adherence, however, remains a barrier to achieving treatment targets., Competing Interests: Authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: HIV disclosure is vital in HIV management. Community Health Workers (CHW) were reported to support partner disclosure among HIV affected heterosexual partners with disclosure difficulties. However, time to disclosure attributed to use of CHW led disclosure support mechanism was not documented. This study compared the incidence of sexual partner disclosure among adults living with HIV (ALHIV) with CHW support and those without in the greater Luwero region, Uganda., Methods: We conducted a quasi-experimental study with two arms allocated by geographically determined clusters and adjusted for between-group differences; among ALHIV in the greater Luwero region of Uganda who had never disclosed to their current primary sexual partners. We allocated study clusters to either a CHW-led intervention or control arm. In both arms, we consecutively recruited participants; those in the intervention arm received CHW disclosure support in addition to routine care. The overall follow-up was six months, and the primary outcome was disclosure to the partner. We used survival analysis with proportional hazard ratios to determine the time to partner disclosure in both arms., Results: A total of 245 participants were enrolled, and 230 (93.9%) completed the study; of these, 112 (48.7%) were in the intervention and 118 (51.3%) in the control arm. The mean age was 31 ± 8 years with a range of 18 to 55 years; the majority were females, 176 (76.5%). The cumulative incidence of disclosure was higher in the intervention arm, 8.76 [95% CI: 7.20-10.67] per 1,000 person-days versus 5.15 [95%CI: 4.85-6.48] per 1,000 person-days in the control arm, log-rank test, X2 = 12.93, P < 0.001. Male gender, aHR = 1.82, tertiary education, aHR = 1.51, and relationship duration of > six months, aHR = 1.19 predicted disclosure. Prior disclosure to a relative, aHR = 0.55, and having more than one sexual partner in the past three months, aHR = 0.74, predicted non-disclosure., Conclusion: CHW-led support mechanism increased the rate of sexual partner disclosure among ALHIV with disclosure difficulties. Therefore, to achieve the global targets of ending HIV, near location CHW-led disclosure support mechanism may be used to hasten HIV disclosure in rural settings., (© 2023. The Author(s).)

Background: HIV status disclosure among sexual partners is vital in HIV management. Community health workers (CHW) support HIV disclosure among adults living with HIV (ALHIV) in sexual relationships with disclosure difficulties. However, experiences and challenges of using CHW-led disclosure support mechanism were not documented. This study explored experiences and challenges involved in using CHW-led disclosure support mechanism among ALHIV in heterosexual relationships in the rural Uganda., Methods: This was a phenomenological qualitative study involving in-depth interviews among CHWs and ALHIV with HIV disclosure difficulties to sexual partners in greater Luwero region, Uganda. We conducted 27 interviews among purposively selected CHWs and participants who had participated in the CHW-led disclosure support mechanism. Interviews were conducted until saturation was reached; and analysis was done using inductive and deductive content analysis in Atlas., Results: All respondents viewed HIV disclosure as an important strategy in HIV management. Provision of adequate counseling and support to those intending to disclose was instrumental for successful disclosure. However, fear of the negative disclosure outcomes was viewed as a barrier to disclosure. The CHWs were viewed as having an added advantage in supporting disclosure as opposed to the routine disclosure counseling. However, HIV disclosure using CHW-led support mechanism would be limited by possible bleach of client's confidentiality. Therefore, respondents thought that appropriate selection of CHWs would improve their trust in the community. Additionally, providing CHWs with adequate training and facilitation during the disclosure support mechanism was viewed to improve their work., Conclusion: Community health workers were viewed as being more supportive in HIV disclosure among ALHIV with disclosure difficulties to sexual partners compared to routine facility based disclosure counseling. Therefore, near location CHW-led disclosure mechanism was acceptable and useful in supporting HIV disclosure among HIV-affected sexual partners in rural settings., (© 2023. The Author(s).)

Background: We evaluated the efficacy of a community health worker (CHW)-led intervention in supporting disclosure among adults living with HIV in heterosexual relationships., Methods: We conducted a quasi-experimental study with 2 arms allocated by geographically determined clusters and adjusted for between-group differences among adults living with HIV in the greater Luwero region of Uganda who had never disclosed their status to their current primary sexual partners. Clusters were allocated to either a CHW-led intervention or a control arm. In both arms, participants were consecutively recruited. As opposed to receiving routine care for the control arm, participants in the intervention arm received additional CHW disclosure support. The overall follow-up was 6 months, and the primary outcome was disclosure to the sexual partner. Data were analyzed using a clustered modified Poisson regression model with robust standard errors to determine independent factors associated with disclosure., Results: Of the 245 participants who enrolled, 230 (93.9%) completed the study, and 112 (48.7%) of those were in the intervention arm. The median age was 30 (interquartile range=25-37) years, the majority were women (76.5%), and most (80%) did not know their partners' HIV status at study entry. At the end of follow-up, the overall disclosure prevalence was 74.4% (95% confidence interval [CI]=68.2, 79.9) and participants in the intervention arm were 51% more likely to disclose compared to those in the control (adjusted relative ratio [aRR]=1.51; 95% CI=1.28, 1.77). Men were 24% (aRR=1.24; 95% CI=1.07, 1.44) more likely to disclose compared to women, and membership in an HIV/AIDS association increased disclosure by 18% (aRR=1.18; 95% CI=1.01, 1.39)., Conclusion: CHW support improved disclosure among adults living with HIV in heterosexual relationships when compared to routine care. Therefore, CHW-led mechanisms may be utilized in increasing disclosure among adults living with HIV in heterosexual relationships in rural settings., (© Lukyamuzi et al.)

Background: The World Health Organization (WHO) recommends the use of pre-exposure prophylaxis (PrEP) in key populations at elevated risk for exposure to HIV. If used effectively, PrEP can reduce annual HIV incidence to below 0.05%. However, PrEP is not acceptable among all communities that might benefit from it. There is, therefore, a need to understand perceptions of PrEP and factors associated with willingness to use PrEP among key populations at risk of HIV, such as members of communities with exceptionally high HIV prevalence., Objective: To examine the perceptions and factors associated with willingness to use oral PrEP among members of fishing communities in Uganda, a key population at risk of HIV., Methods: We conducted an explanatory sequential mixed-methods study at Ggaba fishing community from February to June 2019. Survey data were collected from a systematic random sample of 283 community members in which PrEP had not been rolled out yet by the time of we conducted the study. We carried out bivariate tests of association of willingness to use PrEP with demographic characteristics, HIV risk perception, HIV testing history. We estimated prevalence ratios for willingness to use PrEP. We used backward elimination to build a multivariable modified Poisson regression model to describe factors associated with willingness to use PrEP. We purposively selected 16 participants for focus group discussions to contextualize survey findings, analysing data inductively and identifying emergent themes related to perceptions of PrEP., Key Results: We enrolled 283 participants with a mean age of 31 ± 8 years. Most (80.9%) were male. The majority of participants had tested for HIV in their lifetime, but 64% had not tested in the past 6 months. Self-reported HIV prevalence was 6.4%. Most (80.6, 95%CI 75.5-85.0) were willing in principle to use PrEP. Willingness to use PrEP was associated with perceiving oneself to be at high risk of HIV (aPR 1.99, 95%CI 1.31-3.02, P = 0.001), having tested for HIV in the past 6-months (aPR 1.13, 95%CI 1.03-1.24, P = 0.007), and completion of tertiary education (aPR 1.97, 95%CI 1.39-2.81, P < 0.001). In focus group discussions, participants described pill burden, side-effects and drug safety as potential barriers to PrEP use., Conclusions and Recommendations: Oral PrEP was widely acceptable among members of fishing communities in peri-urban Kampala. Programs for scaling-up PrEP for fisherfolk should merge HIV testing services with sensitization about PrEP and also increase means of awareness of PrEP as an HIV preventive strategy ., (© 2022. The Author(s).)

Background: HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity for improving care and promoting retention assessed by timely attendance of scheduled appointments for the mother-baby pairs and achievement of an HIV-free generation. The objective of this study was to compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care assessed by timely attendance of scheduled appointments over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control)., Methods: In this open label randomized controlled study, one hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 h of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat., Results: At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks]., Conclusions: These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants., Trial Registration: PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449.

Background: The involvement of men in prevention of mother-to-child HIV transmission (PMTCT) programs could accelerate the elimination of vertical transmission. Yet, little research has focused on HIV-positive male partners. This study determined the predictors of male partners' PMTCT knowledge and involvement in a tertiary hospital in northern Nigeria., Methods: A clinic-based sample of 401 HIV-positive male partners of women who delivered within 12 months prior were interviewed using structured questionnaires. PMTCT knowledge and involvement scores were computed. Adjusted odd ratios (AOR) for predictors were derived from multivariate logistic regression models., Results: The proportion of respondents with adequate PMTCT knowledge was 40.9%. Less than half (43.6%) of the respondents participated in PMTCT, with median involvement score of 2.00 (interquartile range, IQR = 0, 5.0). One quarter of respondents (25.7%, n =103) reported >1 sex partners, 10.5% consistently used condoms, and 20.7% had disclosed to all partners. Fathers' involvement in PMTCT was predicted by paternal education (AOR = 0.30; 95% Confidence Interval (CI): 0.12-0.77, no formal vs. post-secondary), HIV-positive child (AOR = 3.85; 95%CI: 1.41-10.54, yes vs. no), treatment duration (AOR = 4.17; 95%CI: 1.67-10.41, ≤1 vs. ≥10 years), disclosure to partner(s) (AOR = 1.21; 95%CI: 1.15-3.52, 'disclosed to all' vs. 'not disclosed'), condom use (AOR = 5.81; 95%CI: 3.07-11.0, always vs. never), and PMTCT knowledge (AOR = 0.62; 95%CI: 0.31-0.92, inadequate versus adequate)., Conclusion: The involvement of fathers in HIV PMTCT programs was low and predicted by paternal education, HIV-positive child, duration of antiretroviral treatment, disclosure to partner, consistent condom use, and level of PMTCT knowledge. Our findings will inform the development of policies to increase male partner involvement in PMTCT in Nigeria., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background: Human Immunodeficiency Virus (HIV), Hepatitis, and Tuberculosis (TB) are three primary communicable infections have the likely potential to cause severe morbidity in prison settings. The prison has the most favorable environment for the transmission of infections. We conducted this survey to determine the prevalence and feasibility of rapid diagnostic tests in an active screening of these infectious diseases in prison., Methods: This cross-sectional survey conducted in central Jail Gaddani, one of the largest prisons in the Balochistan province of Pakistan. All prisoners, jail staffs, and staff's family members participated. Informed consent obtained from each participant before the screening. Van equipped with digital X-ray linked with Computer-Aided Detection for TB (CAD4TB) software used for testing. Sputum samples tested on Xpert for MTB/RIF assay and blood specimens collected for HIV and hepatitis serology. Diagnosed TB patients enrolled for treatment at Basic Management Unit (BMU), reactive on hepatitis Rapid Diagnostic Tools (RDTs) were referred for further testing and management, while HIV reactive referred to Anti Retro Viral (ARV) center for Anti Retro Viral Treatment (ART)., Results: A total of 567 participants offered screening, 63% (356) prisoners, 23% (129) staff's family members, and 14% (82) jail staffs. Among tested 10.3% (58/562) were hepatitis seropositive (Hepatitis-C 41 [7.29%] Hepatitis-B, 16 [2.84%] Hepatitis B&C both, 01 [0.17%]). In reactive participants, 49 were prisoners, 08 were jail staffs, and 01 was the staff's family member. HIV seropositive was 4% (24/566), and all were prisoners. Almost 99% (565/567) screened by digital X-ray, 172 (30%) were with abnormal CAD4TB suggestion (score > 50), out of them sputum of 26% (148) tested on Xpert, and 2% (03) found Mycobacterium tuberculosis Positive (MTB+). A total of five TB patients were detected; out of two were diagnosed clinically. Co-morbidities observed in 15 patients, (01 TB/HIV co-infected, 12 HIV/HCV, 01 HIV/HBV, and 01 HBV/HCV)., Conclusion: The high frequency of infectious diseases in prison is alarming. For limiting the transmission of infections among prison and community, immediate steps are needed to be taken for improvement of prisons condition by application of recommended screening protocols at the time of the first entry of prisoners in prisons.

Objective: Efforts to dual eradication of mother-to-child transmission of human immune deficiency virus (HIV) and syphilis have improved in the previous decades. This has however been hindered by limited validation studies. A cross-sectional study was conducted among adult pregnant women attending antenatal care clinic at Mayuge Health Center III. Two milliliters of venous blood were collected into Ethylene di-amine tetra acetic acid vacutainers, and tested for HIV and syphilis using the SD Bioline HIV/Syphilis Duo assay, and the national HIV and syphilis testing algorithm. Sensitivity and specificity were calculated for the Duo Kit against the gold standards within 95% confidence intervals., Results: Three hundred and eighty-two (382) participants were enrolled. Their mean age was 25.8 years. The prevalence of HIV was 1.8% (95% confidence interval 1.23-2.41); while that of syphilis was 2.1% (95% confidence interval 1.81-2.54), and the dual infection was 0.52% (95% confidence interval 0.37-0.92). The sensitivity and specificity of the SD Bioline HIV/Syphilis Duo assay were all 100.0% (95% confidence interval 99.5 to 100.0 and 98.6 to 100.0, respectively). The performance of the SD Bioline HIV/Syphilis Duo Kit was optimal, reassuring its aptness for use, and favorable qualities to a limited resource setting.

Cell surface expression of α4β7, α4β1 and αEβ7 integrins play a key role in T cell distribution. Understanding the contribution of integrins to the density and ratios of CD4+: CD4negT cell at the portals of entry for HIV is of fundamental importance for the advance of more effective HIV prevention strategies. We therefore set out to characterize and compare the expression of α4β7, α4β1 and αEβ7 integrins on systemic, cervical and rectal CD4+ and CD4negT cells isolated from a cohort of healthy Kenyan women at low risk for sexually transmitted infections (STI) (n = 45). Here we show that blood and cervix were enriched in α4+β1+CD4+T cells and α4+β7hiCD4+T cells, whereas the rectum had an equal frequency of α4+β7hiCD4+T cells and αE+β7hiCD4+T cells. Most cervical and rectal αE+β7hiCD4+T cells expressed CCR5 as well as CD69. Interestingly, αEβ7 was the predominant integrin expressed by CD4negT cells in both mucosal sites, outnumbering αE+β7hiCD4+T cells approximately 2-fold in the cervix and 7-fold in the rectum. The majority of αE+β7hiCD4negT cells expressed CD69 at the mucosa. Taken together, our results show unique tissue-specific patterns of integrin expression. These results can help in guiding vaccine design and also the use of therapeutically targeting integrin adhesion as a means to preventing HIV.

Background:  We report the first-in-human safety and immunogenicity assessment of a prototype intranasally administered, replication-competent Sendai virus (SeV)-vectored, human immunodeficiency virus type 1 (HIV-1) vaccine., Methods:  Sixty-five HIV-1-uninfected adults in Kenya, Rwanda, and the United Kingdom were assigned to receive 1 of 4 prime-boost regimens (administered at 0 and 4 months, respectively; ratio of vaccine to placebo recipients, 12:4): priming with a lower-dose SeV-Gag given intranasally, followed by boosting with an adenovirus 35-vectored vaccine encoding HIV-1 Gag, reverse transcriptase, integrase, and Nef (Ad35-GRIN) given intramuscularly (S L A); priming with a higher-dose SeV-Gag given intranasally, followed by boosting with Ad35-GRIN given intramuscularly (S H A); priming with Ad35-GRIN given intramuscularly, followed by boosting with a higher-dose SeV-Gag given intranasally (AS H ); and priming and boosting with a higher-dose SeV-Gag given intranasally (S H S H )., Results:  All vaccine regimens were well tolerated. Gag-specific IFN-γ enzyme-linked immunospot-determined response rates and geometric mean responses were higher (96% and 248 spot-forming units, respectively) in groups primed with SeV-Gag and boosted with Ad35-GRIN (S L A and S H A) than those after a single dose of Ad35-GRIN (56% and 54 spot-forming units, respectively) or SeV-Gag (55% and 59 spot-forming units, respectively); responses persisted for ≥8 months after completion of the prime-boost regimen. Functional CD8 + T-cell responses with greater breadth, magnitude, and frequency in a viral inhibition assay were also seen in the S L A and S H A groups after Ad35-GRIN boost, compared with those who received either vaccine alone. SeV-Gag did not boost T-cell counts in the AS H group. In contrast, the highest Gag-specific antibody titers were seen in the AS H group. Mucosal antibody responses were sporadic., Conclusions:  SeV-Gag primed functional, durable HIV-specific T-cell responses and boosted antibody responses. The prime-boost sequence appears to determine which arm of the immune response is stimulated., Clinical Trials Registration:  NCT01705990., (© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.)

In this study, we assessed the feasibility of collecting standardized nasal and salivary samples at centers in Nairobi (Kenya), Kigali (Rwanda), and London (United Kingdom) using different collection devices and media (synthetic absorptive matrices versus flocked swabs, and Salimetrics oral swabs versus whole oral fluid collection). We detected anti-Gag (p24) and envelope (gp140) antibodies in both nasal fluid and salivary collections from all HIV-infected individuals, and cross-reactive anti-p24 antibodies were detected in 10% of HIV-uninfected individuals enrolled at one site. Collections from the nasal turbinates were comparable with samples collected deeper in the nasopharyngeal tract, and the yield of anti-p24 IgA in the whole oral fluid samples was higher than in samples collected from the parotid gland. We noted a trend toward reduced levels of anti-HIV antibody in the volunteers receiving anti-retroviral therapy. Levels of antibodies were stable over multiple collection visits. Overall, this study shows that nasal and salivary samples can be collected in a standardized manner over repeated visits in both low- and high-resource settings. These methods may be used in support for future HIV vaccine clinical trials.

Multiple intravaginal HIV prevention methods, including microbicide gels, barriers, and intravaginal rings, are in clinical development in Africa. Development of intravaginal HIV prevention products requires an understanding of sexual behavior, sexually transmitted infection (STI), and vaginitis prevalences, and sexual and vaginal practices in potential target populations. We assessed these factors in a cohort of Kenyan female sex workers (FSW). Women who reported exchanging sex for money/gifts at least three times in the past month and who were HIV uninfected were enrolled and followed for 6 months. STI prevalence and HIV incidence were analyzed by multivariate logistic regression analysis, controlling for demographic and behavioral factors. Thirty-seven percent (74/200) reported having had anal sex. Frequency of anal sex was higher with regular and casual partners than with primary partners. Women were less likely to use condoms for anal sex than for vaginal sex with regular or casual partners. Vaginal washing was universal (100%). HIV incidence was 5.6 per 100 person-years (95% CI 1.62, 11.67). HIV incidence was not associated with any demographic or risk behavior. The relatively high rate of anal sex and universal vaginal washing may complicate both safety and efficacy evaluation of intravaginal products and should be taken into account in trial design. This FSW population had significant HIV incidence and needs continued HIV prevention interventions.

Background: We conducted a double-blind, randomized, placebo-controlled Phase I study of a recombinant replication-defective adenovirus type 5 (rAd5) vector expressing HIV-1 Gag and Pol from subtype B and Env from subtypes A, B and C, given alone or as boost following a DNA plasmid vaccine expressing the same HIV-1 proteins plus Nef, in 114 healthy HIV-uninfected African adults., Methodology/principal Findings: Volunteers were randomized to 4 groups receiving the rAd5 vaccine intramuscularly at dosage levels of 1×10(10) or 1×10(11) particle units (PU) either alone or as boost following 3 injections of the DNA vaccine given at 4 mg/dose intramuscularly by needle-free injection using Biojector® 2000. Safety and immunogenicity were evaluated for 12 months. Both vaccines were well-tolerated. Overall, 62% and 86% of vaccine recipients in the rAd5 alone and DNA prime - rAd5 boost groups, respectively, responded to the HIV-1 proteins by an interferon-gamma (IFN-γ) ELISPOT. The frequency of immune responses was independent of rAd5 dosage levels. The highest frequency of responses after rAd5 alone was detected at 6 weeks; after DNA prime - rAd5 boost, at 6 months (end of study). At baseline, neutralizing antibodies against Ad5 were present in 81% of volunteers; the distribution was similar across the 4 groups. Pre-existing immunity to Ad5 did not appear to have a significant impact on reactogenicity or immune response rates to HIV antigens by IFN-γ ELISPOT. Binding antibodies against Env were detected in up to 100% recipients of DNA prime - rAd5 boost. One volunteer acquired HIV infection after the study ended, two years after receipt of rAd5 alone., Conclusions/significance: The HIV-1 rAd5 vaccine, either alone or as a boost following HIV-1 DNA vaccine, was well-tolerated and immunogenic in African adults. DNA priming increased the frequency and magnitude of cellular and humoral immune responses, but there was no effect of rAd5 dosage on immunogenicity endpoints., Trial Registration: ClinicalTrials.gov NCT00124007.

Background: An understanding of the health of potential volunteers in Africa is essential for the safe and efficient conduct of clinical trials, particularly for trials of preventive technologies such as vaccines that enroll healthy individuals. Clinical safety laboratory values used for screening, enrolment and follow-up of African clinical trial volunteers have largely been based on values derived from industrialized countries in Europe and North America. This report describes baseline morbidity during recruitment for a multi-center, African laboratory reference intervals study., Methods: Asymptomatic persons, aged 18-60 years, were invited to participate in a cross-sectional study at seven sites (Kigali, Rwanda; Masaka and Entebbe, Uganda; Kangemi, Kenyatta National Hospital and Kilifi, Kenya; and Lusaka, Zambia). Gender equivalency was by design. Individuals who were acutely ill, pregnant, menstruating, or had significant clinical findings were not enrolled. Each volunteer provided blood for hematology, immunology, and biochemistry parameters and urine for urinalysis. Enrolled volunteers were excluded if found to be positive for HIV, syphilis or Hepatitis B and C. Laboratory assays were conducted under Good Clinical Laboratory Practices (GCLP)., Results and Conclusions: Of the 2990 volunteers who were screened, 2387 (80%) were enrolled, and 2107 (71%) were included in the analysis (52% men, 48% women). Major reasons for screening out volunteers included abnormal findings on physical examination (228/603, 38%), significant medical history (76, 13%) and inability to complete the informed consent process (73, 13%). Once enrolled, principle reasons for exclusion from analysis included detection of Hepatitis B surface antigen (106/280, 38%) and antibodies against Hepatitis C (95, 34%). This is the first large scale, multi-site study conducted to the standards of GCLP to describe African laboratory reference intervals applicable to potential volunteers in clinical trials. Approximately one-third of all potential volunteers screened were not eligible for analysis; the majority were excluded for medical reasons.

To determine the frequency of hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV) and syphilis infections in Iranian blood donors. The prevalence of serological markers of hepatitis B, hepatitis C, HIV and syphilis infections were evaluated in 318029 consecutive volunteer blood donors attending to Tehran blood transfusion service from March 2005 to March 2006. Those positive for hepatitis B surface antigen, anti-HCV, anti-HIV1/2 and VDRL (venereal disease research laboratory) reactivity were analyzed with a second independent HBsAg enzyme immunoassay (EIA) and neutralization assay; an additional independent anti-HCV EIA and HCV-RIBA assay; second independent anti-HIV1/2 test, HIV western blot and fluorescent Treponemal Antibody Absorbed (FTA-ABS), respectively. In 318029 participants, prevalence of positive HBsAg, HCV RNA, HIV western blot and FTA-ABS was 1684 (0.487%), 323 (0.093%), 11 (0.003%) and 19 (0.005%), respectively. In 1014 subjects randomly selected from these 318029 participants, besides standard interview, physical exam and routine serologic tests; anthropometric and biochemical were studies. In this selected group frequency of HBsAg was 3 (0.29, 95% CI: 0-0.64%); frequency of anti-HCV was 21 (2.07%), but it was (0.09%, 95% CI: 0-0.30%) by confirmatory HCV RNA test; frequency of HIV-Abl, 2 was 8 (0.78%), but it was 2 (0.19%, 95% CI: 0-0.48%) by confirmatory test; frequency of RPR was 0 (0%, 95% CI: 0-0.30%). Despite excluding subjects with high-risk behaviors by standard interview and physical examination, still a few asymptomatic hepatitis B, hepatitis C, HIV-infected subjects existed among volunteer blood donors with demographic and biochemical findings similar to non-infected ones.

Objective: To contrast relief efforts for the 26 December 2004 tsunami with current global HIV/AIDS relief efforts and analyse possible reasons for the disparity., Methods: Literature review and ethical analysis., Results: Just over 273,000 people died in the tsunami, resulting in relief efforts of more than US$10 bn, which is sufficient to achieve the United Nation's long-term recovery plan for South East Asia. In contrast, 14 times more people died from HIV/AIDS in 2004, with UNAIDS predicting a US$8 bn funding gap for HIV/AIDS in developing nations between now and 2007. This disparity raises two important ethical questions. First, what is it that motivates a more empathic response to the victims of the tsunami than to those affected by HIV/AIDS? Second, is there a morally relevant difference between the two tragedies that justifies the difference in the international response? The principle of justice requires that two cases similarly situated be treated similarly. For the difference in the international response to the tsunami and HIV/AIDS to be justified, the tragedies have to be shown to be dissimilar in some relevant respect. Are the tragedies of the tsunami disaster and the HIV/AIDS pandemic sufficiently different, in relevant respects, to justify the difference in scope of the response by the international community?, Conclusion: We detected no morally relevant distinction between the tsunami and the HIV/AIDS pandemic that justifies the disparity. Therefore, we must conclude that the international response to HIV/AIDS violates the fundamental principles of justice and fairness.

Background: Though regular blood transfusion improves the overall survival of patients with beta-thalassemia, it carries a definite risk of infection with blood-borne viruses. We carried out this multicenter study to provide epidemiologic data on hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection among Iranian beta-thalassemic patients. Moreover, HCV infection-associated risk factors were investigated in this population., Methods: Seven hundred and thirty-two patients with beta-thalassemia major or beta-thalassemia intermedia, selected from five provinces of Iran including Tehran (n = 410), Kerman (n = 100), Qazvin (n = 95), Semnan (n = 81), and Zanjan (n = 46), were enrolled in this study. Using ELISA, their sera were tested for HBsAg, HBcAb, HBsAb, HCVAb, and HIVAb. The positive HCVAb results were confirmed by RIBA-2nd generation., Results: The study sample consisted of 413 males and 319 females, with a mean +/- SD age of 17.9 +/- 9.0 years. One hundred forty-one (19.3%) patients were HCVAb positive; 11 (1.5%) were HBsAg positive. No one was HIVAb positive. Univariate analysis showed that beta-thalassemia major (P = 0.01), older age (P = 0.001), longer transfusion duration (P = 0.000), HBsAg seropositivity (P = 0.03), and higher serum ferritin level (P = 0.002) were significantly associated with a higher prevalence of HCV. Furthermore, the prevalence of HCV infection dropped significantly after the implementation of blood donors screening (22.8% vs. 2.6%; P = 0.000). Using multivariate analysis, beta-thalassemia major (P = 0.002), age (P < 0.001), serum ferritin level (P < 0.001), as well as consumption of unscreened blood (P = 0.003), were independent factors associated with HCV infection., Conclusion: The prevalence of HCV infection is much higher among Iranian beta-thalassemic patients as compared with HBV and HIV infections. Routine screening of donated blood for HCV is highly recommended.

In an urban referral clinic, 182 hepatitis C-infected adults including 110 (60%) with HIV coinfection were evaluated for pegylated interferon and ribavirin therapy. Overall, only 33% were eligible for treatment. Considering all patients together, the major barriers to treatment were nonadherence with the evaluation process (23%), refusal of treatment (10%), active substance abuse (9%), and medical contraindication (8%). There was a trend toward a higher rate of treatment eligibility in HIV coinfected patients (39% vs. 25%; p = 0.07), who were significantly more likely to be adherent with the evaluation process compared to those with hepatitis C alone (86% vs. 63%; p = <0.001). Acceptance of antiviral therapy for hepatitis C was similar between eligible persons with and without HIV. These findings highlight the need to develop interventions to improve adherence and to manage substance abuse and other comorbidities in order to maximize the impact of interferon and ribavirin therapy on urban patients with hepatitis C.