Condom use behaviour among people living with HIV: a seven-country community-based participatory research in the Asia-Pacific region.

OBJECTIVES: We examined the prevalence of inconsistent condom use and its correlates among people living with HIV (PLHIV) in the Asia-Pacific region. METHODS: Between 1 October 2012 and 31 May 2013, a total of 7843 PLHIV aged 18-50 years were recruited using targeted and venue-based sampling in Bangladesh, Indonesia, Lao People's Democratic Republic (PDR), Nepal, Pakistan, Philippines and Vietnam. Logistic regression was used to explore the association between condom use behaviour and demographics, social support, stigma and discrimination and various health-related variables. RESULTS: Overall, 43% of 3827 PLHIV practised inconsistent condom use at sexual intercourse with their regular partner. An even higher proportion, 46% of 2044 PLHIV admitted that they practised unprotected sex with a casual partner. Participants from Lao PDR reported the lowest prevalence of inconsistent condom use for both regular and casual partners, while participants from the Philippines had the highest risk behaviour. Inconsistent condom use was significantly associated with belonging to a key population (drug user, sex worker or refugee subpopulation), not knowing that condoms are still needed if both partners are HIV positive, having a regular partner whose HIV status was either positive or unknown, having experienced physical assault and not receiving antiretroviral treatment. CONCLUSIONS: This large seven-country study highlights a high prevalence of inconsistent condom use among PLHIV in the Asia-Pacific region. In addition to knowledge-imparting interventions, the adoption and expansion of the 'Test and Treat' strategy could help to maximise the prevention benefits of antiretroviral treatment.

The relationship between HIV and fertility in the era of antiretroviral therapy in sub-Saharan Africa: evidence from 49 Demographic and Health Surveys.

OBJECTIVES: To describe regional differences in the relative fertility of HIV-positive vs. HIV-negative women and changes as antiretroviral treatment (ART) is scaled up, to improve estimates of predicted need for and coverage of prevention of mother-to-child transmission services at national and subnational levels. METHODS: We analysed 49 nationally representative household surveys in sub-Saharan Africa between 2003 and 2016 to estimate fertility rate ratios of HIV-positive and HIV-negative women by age using exponential regression and test for regional and urban/rural differences. We estimated the association between national ART coverage and the relationship between HIV and fertility. RESULTS: Significant regional differences exist in HIV and fertility relationships, with less HIV-associated subfertility in Southern Africa. Age patterns of relative fertility are similar. HIV impact on fertility is weaker in urban than rural areas. For women below age 30, regional and urban/rural differences are largely explained by differences in age at sexual debut. Higher levels of national ART coverage were associated with slight attenuation of the relationship between HIV and fertility. CONCLUSIONS: Regional differences in HIV-associated subfertility and urban-rural differences in age patterns of relative fertility should be accounted for when predicting need for and coverage of PMTCT services at national and subnational level. Although HIV impacts on fertility are somewhat reduced at higher levels of national ART coverage, differences in fertility between HIV positive and negative remain, and fertility of women on ART should not be assumed to be the same as HIV-negative women. There were few data in recent years, when ART has reached high levels, and this relationship should continue to be assessed as further evidence becomes available.

The effect of women's property rights on HIV: a search for quantitative evidence.

In recent years, efforts to reduce HIV transmission have begun to incorporate a structural interventions approach, whereby the social, political, and economic environment in which people live is considered an important determinant of individual behaviors. This approach to HIV prevention is reflected in the growing number of programs designed to address insecure or nonexistent property rights for women living in developing countries. Qualitative and anecdotal evidence suggests that property ownership may allow women to mitigate social, economic, and biological effects of HIV for themselves and others through increased food security and income generation. Even so, the relationship between women's property and inheritance rights (WPIR) and HIV transmission behaviors is not well understood. We explored sources of data that could be used to establish quantitative links between WPIR and HIV. Our search for quantitative evidence included (1) a review of peer-reviewed and "gray" literature reporting on quantitative associations between WPIR and HIV, (2) identification and assessment of existing data-sets for their utility in exploring this relationship, and (3) interviews with organizations addressing women's property rights in Kenya and Uganda about the data they collect. We found no quantitative studies linking insecure WPIR to HIV transmission behaviors. Data-sets with relevant variables were scarce, and those with both WPIR and HIV variables could only provide superficial evidence of associations. Organizations addressing WPIR in Kenya and Uganda did not collect data that could shed light on the connection between WPIR and HIV, but the two had data and community networks that could provide a good foundation for a future study that would include the collection of additional information. Collaboration between groups addressing WPIR and HIV transmission could provide the quantitative evidence needed to determine whether and how a WPIR structural intervention could decrease HIV transmission.

Enhancing retention of an Internet-based cohort study of men who have sex with men (MSM) via text messaging: randomized controlled trial.

BACKGROUND: Black and Hispanic men who have sex with men (MSM) are disproportionately affected by HIV in the United States. The Internet is a promising vehicle for delivery of HIV prevention interventions to these men, but retention of MSM of color in longitudinal Internet-based studies has been problematic. Text message follow-up may enhance retention in these studies. OBJECTIVE: To compare retention in a 12-month prospective Internet-based study of HIV-negative MSM randomized to receive bimonthly follow-up surveys either through an Internet browser online or through text messages. METHODS: Internet-using MSM were recruited through banner advertisements on social networking and Internet-dating sites. White, black, and Hispanic men who were ≥18, completed an online baseline survey, and returned an at-home HIV test kit, which tested HIV negative, were eligible. Men were randomized to receive follow-up surveys every 2 months on the Internet or by text message for 12 months (unblinded). We used time-to-event methods to compare the rate of loss-to-follow-up (defined as non-response to a follow-up survey after multiple systematically-delivered contact attempts) in the 2 follow-up groups, overall and by race/ethnicity. Results are reported as hazard ratios (HR) and 95% confidence intervals (CI) of the rate of loss-to-follow-up for men randomized to text message follow-up compared to online follow-up. RESULTS: Of 1489 eligible and consenting men who started the online baseline survey, 895 (60%) completed the survey and were sent an at-home HIV test kit. Of these, 710 of the 895 (79%) returned the at-home HIV test kit, tested HIV-negative, and were followed prospectively. The study cohort comprised 66% white men (470/710), 15% (106/710) black men, and 19% (134/710) Hispanic men. At 12 months, 77% (282/366) of men randomized to online follow-up were retained in the study, compared to 70% (241/344) men randomized to text message follow-up (HR=1.30, 95% CI 0.97-1.73). The rate of loss-to-follow-up was non-significantly higher in the text message arm compared to the online arm for both white (HR=1.43, 95% CI 0.97-1.73) and Hispanic men (HR=1.71, 95% CI 0.91-3.23); however, loss-to-follow-up among black men was non-significantly lower among those who received text message follow-up compared to online follow-up (HR=0.78, 95% CI 0.41-1.50). In the online arm, black men were significantly more likely to be lost to follow-up compared to white men (HR=2.25, 95% CI 1.36-3.71), but this was not the case in the text message arm (HR=1.23, 95% CI 0.70-2.16). CONCLUSIONS: We retained >70% of MSM enrolled in an online study for 12 months; thus, engaging men in online studies for a sufficient time to assess sustained outcomes is possible. Text message follow-up of an online cohort of MSM is feasible, and may result in higher retention among black MSM.

Understanding Retention in the HIV Pre-Exposure Prophylaxis Cascade Among Cisgender Women.

HIV remains a significant public health concern in the United States, with 34,800 new cases diagnosed in 2019; of those, 18% were among women. Oral pre-exposure prophylaxis (PrEP) with daily tenofovir disoproxil fumarate/emtricitabine is effective and safe, reducing HIV transmission by up to 92% in women. Though studies demonstrate low rates of PrEP adherence among cisgender women prescribed oral PrEP, little is known about the factors that shape PrEP continuation among them. This study focuses on understanding the experiences of cisgender women who have initiated PrEP to gain insight into the factors that shape PrEP continuation. We conducted semi-structured interviews with (N = 20) women who had been prescribed oral PrEP. Interviews were guided by the social-ecological framework to identify multilevel factors affecting PrEP continuation; we specifically examined the experience of engagement and retention in the PrEP cascade. We recruited women who had been prescribed oral PrEP by a government-sponsored sexual health center or a hospital-based family planning clinic in Washington, DC. Factors facilitating PrEP continuation included a positive emotional experience associated with PrEP use, high perceived risk of HIV acquisition, and high-quality communication with health care providers. The most common reason for PrEP discontinuation was low perceived HIV risk (n = 11). Other factors influencing discontinuation were side effects, a negative emotional experience while using PrEP, and negative interactions with the health care system. This study underscores the importance of specific multi-level factors, including the provision of high-quality communication designed to resonate with women and shared decision making between women and their health care providers.

Selecting implementation strategies to improve implementation of integrated PrEP for pregnant and postpartum populations in Kenya: a sequential explanatory mixed methods analysis.

BACKGROUND: There is a higher risk for HIV acquisition during pregnancy and postpartum. Pre-exposure prophylaxis (PrEP) is recommended during this period for those at high risk of infection; integrated delivery in maternal and child health (MCH) clinics is feasible and acceptable but requires implementation optimization. METHODS: The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged stakeholders to prioritize determinants of PrEP delivery (using Likert scores) and prioritize PrEP delivery implementation strategies. Using a sequential explanatory mixed methods design, we conducted quantitative surveys with healthcare workers at 55 facilities in Western Kenya and a stakeholder workshop (including nurses, pharmacists, counselors, and county and national policymakers), yielding visual plots of stakeholders' perceived feasibility and effectiveness of the strategies. A stepwise elimination process was used to identify seven strategies for empirical testing. Facilitator debriefing reports from the workshop were used to qualitatively assess the decision-making process. RESULTS: Among 146 healthcare workers, the strongest reported barriers to PrEP delivery were insufficient providers and inadequate training, insufficient space, and high volume of patients. Sixteen strategies were assessed, 14 of which were included in the final analysis. Among rankings from 182 healthcare workers and 44 PrEP policymakers and implementers, seven strategies were eliminated based on low post-workshop ranking scores (bottom 50th percentile) or being perceived as low feasibility or low effectiveness for at least 50% of the workshop groups. The top seven strategies included delivering PrEP within MCH clinics instead of pharmacies, fast-tracking PrEP clients to reduce waiting time, delivering PrEP-related health talks in waiting bays, task shifting PrEP counseling, task shifting PrEP risk assessments, training different providers to deliver PrEP, and retraining providers on PrEP delivery. All top seven ranked strategies were grouped into bundles for subsequent testing. Facilitator debriefing reports generally aligned with rankings but noted how stakeholders' decision-making changed when considering the impact of strategies on facility staff and non-PrEP clients. CONCLUSIONS: The most impactful barriers to integrated PrEP delivery in MCH clinics were insufficient staffing and space. Implementation strategies prioritized through multiple methods of stakeholder input focused on co-location of services and increasing clinic efficiency. Future testing of these stakeholder-prioritized strategy bundles will be conducted to assess the effectiveness and implementation outcomes.

Does a youth intern programme strengthen HIV service delivery in South Africa? An interrupted time-series analysis.

INTRODUCTION: Since 2018, Youth Health Africa (YHA) has placed unemployed young adults at health facilities across South Africa in 1-year non-clinical internships to support HIV services. While YHA is primarily designed to improve employment prospects for youth, it also strives to strengthen the health system. Hundreds of YHA interns have been placed in programme (e.g. HIV testing and counselling) or administrative (e.g. data and filing) roles, but their impact on HIV service delivery has not been evaluated. METHODS: Using routinely collected data from October 2017 to March 2020, we conducted an interrupted time-series analysis to explore the impact of YHA on HIV testing, treatment initiation and retention in care. We analysed data from facilities in Gauteng and North West where interns were placed between November 2018 and October 2019. We used linear regression, accounting for facility-level clustering and time correlation, to compare trends before and after interns were placed for seven HIV service indicators covering HIV testing, treatment initiation and retention in care. Outcomes were measured monthly at each facility. Time was measured as months since the first interns were placed at each facility. We conducted three secondary analyses per indicator, stratified by intern role, number of interns and region. RESULTS: Based on 207 facilities hosting 604 interns, YHA interns at facilities were associated with significant improvements in monthly trends for numbers of people tested for HIV, newly initiated on treatment and retained in care (i.e. loss to follow-up, tested for viral load [VL] and virally suppressed). We found no difference in trends for the number of people newly diagnosed with HIV or the number initiating treatment within 14 days of diagnosis. Changes in HIV testing, overall treatment initiation and VL testing/suppression were most pronounced where there were programme interns and a higher number of interns; change in loss to follow-up was greatest where there were administrative interns. CONCLUSIONS: Placing interns in facilities to support non-clinical tasks may improve HIV service delivery by contributing to improved HIV testing, treatment initiation and retention in care. Using youth interns as lay health workers may be an impactful strategy to strengthen the HIV response while supporting youth employment.

Integrating HIV Pre-Exposure Prophylaxis (PrEP) Education During Medical Residency: Training Outcomes and Suggestions for Learning Effectiveness.

Human immunodeficiency virus (HIV) infection is now preventable with pre-exposure prophylaxis (PrEP) drugs, however, barriers to PrEP implementation include primary-care physician (PCP) knowledge-gap and lack of comfort prescribing and managing PrEP. We hypothesized that integrating HIV-PrEP education during medical-residency would help address these problems and developed a 40-minute case-based lecture focused on the 2021 United States Preventative Services Taskforce (USPSTF) oral HIV-PrEP guidelines and integrated this into our residency's core curriculum. We analyzed data from physician-trainees who voluntarily completed a pre- and post-lecture survey measuring HIV-PrEP "knowledge" and "self-assessed readiness to independently initiate and manage PrEP." Independent group analysis was completed via the Mann-Whitney U and Pearson Chi-square 2-sided test with P-value <0.05 deemed significant. Of the total of 189 residents invited to the lecture, 130 (69%) completed the pre-survey while 107 (57%) completed the post-survey. Per knowledge-assessment: the median number of correctly answered questions rose from a pre-lecture baseline of 4/9 (44%) to 8/9 (89%) following the education intervention (P < .001). When asked about comfort initiating and managing HIV-PrEP on their own, 7/130 (5.4%) responded in agreement pre-lecture, but this rose to 55/107 (51.4%) post-lecture (P < .001). Our study revealed PrEP training during residency was effective per stated objectives and may be an important tool to increase PrEP delivery/uptake to achieve the target goals for the National HIV/AIDS Strategy.

Implementation of an Educational Intervention to Improve HIV Pre-Exposure Prophylaxis Services for Women in an Urban Sexual Health Clinic.

To test the hypothesis that implementation of a multicomponent, educational HIV pre-exposure prophylaxis (PrEP) intervention to promote universal PrEP services for cisgender women (subsequently "women") in sexual and reproductive health centers would improve the proportion of women screened, offered, and prescribed PrEP, we implemented a multicomponent, educational intervention in a Washington D.C. Department of Health-sponsored sexual health clinic. The clinic serves a patient population with high-potential exposure to HIV. The intervention included clinic-wide PrEP trainings, an electronic health record prompt for PrEP counseling by providers, and educational videos in the waiting room. We collected preimplementation data from March 22, 2018 to July 4, 2018, including 331 clinical encounters for 329 women. Between July 5, 2018 and July 1, 2019, there were 1733 clinical encounters for 1720 HIV-negative women. We used mixed methods to systematically assess intervention implementation using the Reach Effectiveness Adoption Implementation Maintenance framework. Additionally, we assessed the interventions' acceptability and feasibility among providers through semistructured interviews. The proportion of women screened by providers for PrEP (5.6% preimplementation to a mean of 89.2% of women during the implementation period, p < 0.01), offered (6.2 to 69.8%, p < 0.01), and prescribed PrEP (2.6 to 8.1%, p < 0.01) by providers increased significantly in the implementation period. Providers and clinic staff found the intervention both highly feasible and acceptable and demonstrated increased knowledge of PrEP and HIV prevention associated with the clinic-wide trainings. Our results demonstrate the effectiveness of a low-cost educational intervention to increase provision of integrated PrEP services in an urban sexual health clinic serving women with high-potential exposure to HIV. ClinicalTrials.gov ID NCT03705663.

Effectiveness of Cash Transfer Delivered Along With Combination HIV Prevention Interventions in Reducing the Risky Sexual Behavior of Adolescent Girls and Young Women in Tanzania: Cluster Randomized Controlled Trial.

BACKGROUND: Poverty and social inequality exacerbate HIV risk among adolescent girls and young women (AGYW) in sub-Saharan Africa. Cash transfers can influence the structural determinants of health, thereby reducing HIV risk. OBJECTIVE: This study assessed the effectiveness of cash transfer delivered along with combination HIV prevention (CHP) interventions in reducing the risky sexual behavior of AGYW in Tanzania. The incidence of herpes simplex virus type 2 (HSV-2) infection was used as a proxy for sexual risk behavior. METHODS: A cluster randomized controlled trial was conducted in 15 matched pairs of communities (1:1 intervention to control) across 3 strata (urban, rural high-risk, and rural low-risk populations) of the Shinyanga Region, Tanzania. The target population was out-of-school AGYW aged 15-23 years who had completed 10-hour sessions of social and behavior change communication. Eligible communities were randomly assigned to receive CHP along with cash transfer quarterly (intervention group) or solely CHP interventions (control group) with no masking. Study recruitment and baseline survey were conducted between October 30, 2017 and December 1, 2017. Participants completed an audio computer-assisted self-interview, HIV counselling and testing, and HSV-2 testing at baseline and during follow-up visits at 6, 12, and 18 months after the baseline survey. A Cox proportional hazards model with random effects specified at the level of clusters (shared frailty) adjusted for matching pairs and other baseline imbalances was fitted to assess the effects of cash transfer on the incidence of HSV-2 infection (primary outcome). Secondary outcomes included HIV prevalence at follow-up, self-reported intergenerational sex, and self-reported compensated sex. All secondary outcomes were measured at each study visit. RESULTS: Of the 3026 AGYW enrolled in the trial (1482 in the intervention and 1544 in the control), 2720 AGYW (1373 in the intervention and 1347 in the control) were included in the final analysis. Overall, HSV-2 incidence was not significantly different at all follow-up points between the study arms in the adjusted analysis (hazard ratio 0.96, 95% CI 0.67-1.38; P=.83). However, HSV-2 incidence was significantly lower in the rural low-risk populations who received the cash transfer intervention (hazard ratio 0.45, 95% CI 0.29-0.71; P=.001), adjusted for potential confounders. CONCLUSIONS: Although this trial showed no significant impact of the cash transfer intervention on HSV-2 incidence among AGYW overall, the intervention significantly reduced HSV-2 incidence among AGYW in rural low-risk communities. Factors such as lesser poverty and more asset ownership in urban and rural high-risk communities may have undermined the impact of cash transfer. TRIAL REGISTRATION: ClinicalTrials.gov NCT03597243; https://clinicaltrials.gov/show/NCT03597243.

India to develop its own AIDS vaccine.

PIP: UNAIDS believes that more than 3 million Indians are infected with HIV, approximately 200,000 of which have AIDS. Failing in its attempt to check the spread of HIV/AIDS through disease prevention messages and the promotion of condom use, the government of India has launched a program to develop a vaccine against HIV/AIDS. Some see the development of a vaccine as the only viable course of action against HIV/AIDS in India, for educational campaigns have failed and AIDS drugs are unaffordable even for wealthy Indians. Interest in producing an indigenous vaccine stems from concern that vaccines being developed in the West may not be effective in India due to differences in HIV subtypes. A 5-year extension of an existing Indo-US program started in 1987 to develop vaccines against a range of infectious diseases was signed in December 1997, with AIDS added to the list of original program diseases. This revised agreement includes collaboration with US vaccine research groups and possible US funding, but details of the terms have yet to be disclosed. The following Indian teams are working on the project: the government Department of Biotechnology (DBT), the All India Institute of Medical Sciences, the National Institute of Communicable Diseases (New Delhi), Christian Medical College (Vellore), and the National AIDS Research Institute (Pune). The DBT argues that there will be enough funding even without a US contribution. Indian scientists plan to develop a DNA vaccine mixture containing the desired gene sequences of the HIV subtypes which are prevalent in India.^ieng

Ethical considerations of clinical trials to prevent vertical transmission of HIV in developing countries.

PIP: The Public Citizen's Health Research Group recently called attention to ethical concerns with trials of AZT which are either planned or underway in developing countries. The trials are being conducted to determine the minimum dose of AZT needed to prevent the vertical transmission of HIV from infected mothers to their unborn children. To that end, women who have given their informed consent to enter the trials are randomized into various dosage and placebo arms of the trials. The problem with this standard trial format in this case is that AZT is already proven capable of blocking approximately two thirds of transmissions of HIV to the fetus. The Public Citizen's Health Research Group therefore argues that the trials violate the Helsinki Declaration in that every patient enrolled in a clinical trial should be assured of receiving the best available treatment. Since these study subjects cannot obtain HIV prophylaxis elsewhere, they may enter the trials out of desperation, thereby invalidating their ability to autonomously consent to study participation. The author considers the ideal of informed consent which equates autonomy with competence rather than with freedom, whether freedom equals choice, and freedom, autonomy, and trials in developing countries. AZT vertical transmission trials could be markedly improved by replacing the placebo arm with a contrasting dose cohort.^ieng

Indian state plans compulsory HIV testing, segregation and branding.

PIP: Health officials in the Indian state of Maharashtra have ordered the compulsory testing of all girls 12 years and older who live in designated "destitute homes." The officials also plan to tattoo a symbol on the thighs of all HIV-positive prostitutes. By April 1998, this December 1997 order had resulted in the compulsory testing of women living in 50 boarding houses and the transfer of several found to be HIV-positive to a separate institution 200 miles from the state capital. Nongovernment organizations (NGOs) have mounted a protest over this statute, but state governments in India are free to enact their own health laws. The Maharashtran government is also seeking to legalize prostitution and to force prostitutes to register with a Board that will be able to order compulsory HIV tests and tattooing. Women with HIV who continue to engage in prostitution will be quarantined, and their clients will be jailed. In response, prostitutes in the capital city of Mumbai have threatened to release a list of their client's names to the press. The only recourse available to NGOs who oppose this action is to generate a large enough public outcry to stop it. A Mumbai-based attorney noted that many private companies are also requiring HIV testing and dismissing those who test positive.^ieng

Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: The HIV epidemic in Eastern and Southern Africa is characterized by a high incidence and prevalence of HIV infection among adolescent girls and young women (AGYW) aged 15-24 years. For instance, in some countries, HIV prevalence in AGYW aged 20-24 years exceeds that in AGYW aged 15-19 years by 2:1. Sauti (meaning voices), a project supported by the United States Agency for International Development, is providing HIV combination prevention interventions to AGYW in the Shinyanga region, Tanzania. OBJECTIVE: The aim of this study is to determine the impact of cash transfer on risky sexual behavior among AGYW receiving cash transfer and HIV combination prevention interventions. This paper describes the research methods and general protocol of the study. Risky sexual behavior will be assessed by herpes simplex virus type 2 (HSV-2) incidence, compensated sex (defined as sexual encounters motivated by exchange for money, material support, or other benefits), and intergenerational sex (defined as a sexual partnership between AGYW and a man 10 or more years older). Through a qualitative study, the study seeks to understand how the intervention affects the structural and behavioral drivers of the HIV epidemic. METHODS: The trial employs audio computer-assisted self-interviewing, participatory group discussions (PGDs), and case studies to collect data. A total of 30 matched villages (15 intervention and 15 control clusters) were randomized to either receive cash transfer delivered over 18 months in addition to other HIV interventions (intervention arm) or to receive other HIV interventions without cash transfer (control arm). Study participants are interviewed at baseline and 6, 12, and 18 months to collect data on demographics, factors related to HIV vulnerabilities, family planning, sexual risk behavior, gender-based violence, and HSV-2 and HIV infections. A total of 6 PGDs (3 intervention, 3 control) were conducted at baseline to describe perceptions and preferences of different intervention packages, whereas 20 case studies are used to monitor and unearth the dynamics involved in delivery and uptake of cash transfer. RESULTS: The study was funded in June 2017; enrollment took place in December 2017. A total of two rounds of the follow-up survey are complete, and one round has yet to be conducted. The results are expected in December 2019 and will be disseminated through conferences and peer-reviewed publications. CONCLUSIONS: This study will document the synergetic impact of cash transfer in the presence of HIV combination prevention interventions on risky sexual behavior among out-of-school AGYW. The results will strengthen the evidence of cash transfer in the reduction of risky sexual behavior and provide feasible HIV prevention strategies for AGYW. TRIAL REGISTRATION: Clinicaltrials.gov NCT03597243; https://clinicaltrials.gov/ct2/show/NCT03597243. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14696.

The development of a national HIV Plan in Belgium: Achieving consensus despite institutional complexity.

BACKGROUND: The development of a national HIV Plan poses serious challenges to countries with a complex distribution of legal powers such as Belgium. This article explores how the Belgian national HIV Plan 2014-2019 was developed. METHODS: Applying the policy streams model of John Kingdon, the analysis of the HIV Plan development process was based on published government statements, parliamentary documents, and websites of stakeholders. RESULTS: The Federal Ministry of Health initiative to achieve the HIV Plan was characterized by a coordinating role with a participatory approach towards the other Belgian governments and stakeholders. The 2013 protocol agreement of the Belgian governments committed them to principles, actions, and cooperation, but not to budgets, priorities, or target figures. DISCUSSION: The Federal government followed a successful strategy to create momentum and commitment to a common national vision on HIV/AIDS. The window of opportunity was not sufficient to create an implementation plan prior to the 2014 elections, and major challenges were left to the subsequent governments, including financing. CONCLUSION: The country of Belgium represents an example of a consensus strategy to achieve a national HIV Plan with its achievements and limits within institutional complexity and limited Federal legal powers.

Sensitivity of HIV-antibody assays determined by seroconversion panels.

OBJECTIVES: To determine the sensitivity of HIV-antibody assays for detecting low levels of HIV antibody using seroconversion and other panels containing plasma of varying titres. METHODS: Eight HIV-antibody assays, available under the World Health Organization bulk-procurement agreement, were evaluated on sets of sequential plasma samples derived from 11 individuals who had recently become HIV-infected (seroconversion panels). In addition, two non-seroconversion panels, consisting of low performance (titre) and mixed titre samples were used to further define the sensitivity of the assays. The eight assays included two rapid tests, one simple test, and five enzyme-linked immunosorbent assays (ELISA). RESULTS: On average, the eight assays detected antibody 0.5-4.8 days later than the reference test (Abbott HIV-1/HIV-2 3rd generation ELISA); these differences were statistically significant for six of the eight tests. All tests performed well on the low performance and mixed titre panels. All eight assays also had comparable sensitivity to that of the reference test on a large panel of known positive plasma. The additional risk of missing an infectious unit of blood during seroconversion by using the least sensitive rather than the reference test was estimated to be 1 in 7600 and 1 in 76 million at annual HIV incidence rates of 1 and 0.0001%, respectively. The cost of eliminating this additional risk by using the reference test is between US$ 15,150 and 151 million per unit detected at the above incidence rates. CONCLUSIONS: Although there are differences in sensitivity between the assays when used to test blood from individuals during the course of seroconversion, the differences are small, and all eight tests are appropriate for use as screening tests.

Male circumcision: a role in HIV prevention?

PIP: Speculation has existed for decades on the association between the lack of male circumcision and the sexual transmission of disease. It has been suggested that the surface epithelium of the glans develops a protective keratin layer following circumcision which functions like a natural condom against contracting disease. Circumcised males may therefore be less susceptible to contracting sexually transmitted diseases (STD), including HIV. The identification of simian immunodeficiency virus-infected mononuclear cells in the dermis and epidermis of the penile foreskin of macaques also suggests that male circumcision may reduce the infectivity of men with HIV. The authors review the evidence in support of the association between the lack of circumcision and STDs, and the possible biological explanations. They also discuss the implications for public health interventions and suggest areas and methods for further research. Twenty-three published study reports linking circumcision status to HIV infection are identified and include retrospective studies including partner studies, cross-sectional serosurveys, a longitudinal study, and ecological correlations. Five studies linked the lack of circumcision to STDs other than HIV infection. In interpreting the data, the authors consider susceptibility versus infectivity, assessment of behaviors and adjustment for confounding, selection bias, misclassification of exposure, measure of association, and publication bias. It is ultimately concluded that more studies are needed to quantify the relative risk associated with the lack of male circumcision. Observational designs could be employed to that end along with laboratory and primate research.^ieng

One world, one hope: the cost of providing antiretroviral therapy to all nations.

OBJECTIVE: To estimate the potential direct cost of making triple combination antiretroviral therapy widely available to HIV-positive adults and children living in countries throughout the world. METHODS: For each country, antiretroviral costs were obtained by multiplying the annual cost of triple antiretroviral therapy by the estimated number of HIV-positive persons accessing therapy. Per capita antiretroviral costs were computed by dividing the antiretroviral costs by the country's total population. The potential economic burden was calculated by dividing per capita antiretroviral costs by the gross national product (GNP) per capita. All values are expressed in 1997 US dollars. RESULTS: The potential cost of making triple combination antiretroviral therapy available to HIV-positive individuals throughout the world was estimated to be over US$ 65.8 billion. By far the greatest financial burden was on sub-Saharan Africa. The highest per capita drug cost in this region would be incurred in the subregions of Southern Africa (US$ 149) followed by East Africa (US$ 116), Middle Africa (US$ 44), and West Africa (US$ 42). In the Americas, subregional data indicated the highest per capita drug cost would be in the Latin Caribbean (US$ 22), followed by the Caribbean (US$ 17), Andean Area (US$ 7), the Southern Cone (US$ 6), North America (US$ 6), and Central American Isthmus (US$ 5). In Asia and Europe the percentage of the GNP necessary to finance drug therapy was less than 1% in most countries examined. CONCLUSION: Our results demonstrate that the cost of making combination antiretroviral therapy available worldwide would be exceedingly high, especially in countries with limited financial resources.

PIP: In 1997, an estimated 5.8 million people worldwide were infected with HIV, of whom 90% lived in developing countries, especially in sub-Saharan Africa. While antiretroviral therapy has been shown to prolong survival in people with HIV/AIDS, many of the countries with the highest rates of HIV infection have little or no access to antiretroviral therapy, for a number of reasons, including cost. Findings are presented from a study conducted to estimate the potential direct cost of making triple combination antiretroviral therapy widely available to all of the world's HIV-infected population. The potential cost of making such therapy available to HIV-positive people worldwide was estimated to be over US$65.8 billion, in 1997 US dollars, with the greatest expenditures needed in sub-Saharan Africa. The highest per capita drug cost in sub-Saharan Africa would be incurred in Southern Africa (US$149), followed by East Africa (US$116), Middle Africa (US$44), and West Africa (US$42). In the Americas, per capita drug costs would be US$22 in the Latin Caribbean, US$17 in the Caribbean, US$7 in the Andean Area, US$6 in the Southern Cone and North America, and US$5 in the Central American Isthmus. In Europe and Asia, the percentage of GNP needed to finance drug therapy was less than 1% in most countries examined. For each country, antiviral costs were determined by multiplying the annual cost of triple antiretroviral therapy by the estimated number of HIV-positive people accessing therapy. Per capita therapy costs were calculated by dividing the antiretroviral costs by the country's total population. The potential economic burden was calculated by dividing per capita antiretroviral costs by the gross national product (GNP) per capita.

Prevention of HIV transmission by blood transfusion in the developing world: achievements and continuing challenges.

In industrialized countries, the use of sensitive HIV screening tests, donor deferral, and more conservative use of blood have resulted in a dramatic decrease in the transmission of HIV infection by blood transfusion. The risk of HIV transmission in the USA by blood screened negative for HIV antibody was recently estimated at one in 440,000-660,000 donations. Despite this low risk, continued public concern has compelled blood collection agencies and policy makers to continue to search for more sensitive HIV screening tests. Genome amplification techniques are receiving increased attention and are being piloted in Germany. HIV-1 p24 antigen testing was implemented in the USA in March 1996. In the first 18 months of p24 antigen testing, an estimated 18 million blood donations were tested at a cost of US$90 million to detect three antigen-positive, antibody-negative donations. However, in many developing countries where severe anemia is widespread and the prevalence of HIV infection among blood donors is orders of magnitude greater than in industrialized countries, the blood supply is either incompletely screened or not screened at all for HIV antibody. Although the contribution of transfusion-transmitted infection to the HIV epidemic has not been accurately assessed, an estimated 5-10% of HIV infections in developing countries are due to blood transfusion. In a study conducted 1 year after implementation of HIV blood screening in the largest hospital in the capital city of the Democratic Republic of the Congo, an estimated 25% of pediatric HIV infections, and 40% of infections among children over 1 years of age, were due to transfusion. Lack of commitment by national governments and international aid organizations to this fundamental element of HIV prevention has resulted in a shortage of basic equipment, supplies, and trained personnel for blood screening. Moreover, provision of test kits alone cannot prevent HIV transmission by transfusion in resource-poor areas. More comprehensive programs are needed to improve the recruitment and retention of safe donors, essential laboratory services for blood banking and screening, technical training and supervision, appropriate use of transfusions, and the prevention of severe anemia. This article summarizes the steps being taken by developing countries to prevent HIV transmission by blood transfusion, lessons learned, and the work that still lies ahead.

PIP: Screening of the blood supply, a cost-effective strategy for reducing HIV transmission, has not been implemented consistently in developing countries. An estimated 5-10% of HIV transmission in these countries remains attributable to blood transfusion. Lack of commitment by national governments and international aid organizations has resulted in a shortage of basic equipment, supplies, and trained personnel for blood screening. The situation is further complicated by problems recruiting and retaining safe donors, a lack of essential laboratory services for blood banking and screening, the nonavailability of rapid tests, inadequate supervision of personnel, and widespread need for blood transfusions for malaria-related severe anemia. International donor organizations, government agencies, and health care providers are urged to give renewed attention to the issue of blood safety in resource-poor areas of the world so that this effective method of HIV prevention can be universally accessible.