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Experimental HIV treatment models highlight success, obstacles to expanding care

The UNAIDS fast track strategy seeks to ensure that 90% of HIV-positive people know their status, 90% are able to access antiretroviral treatment (ART), and 90% of those on treatment attain viral suppression, by the year 2020. Studies on treatment expansion in several southern and East African countries provide new insights on how to achieve the 90-90-90 objectives, while also identifying critical obstacles to overcome.

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Researchers in developing countries with high burdens of HIV infection are developing promising new strategies to advance towards global HIV treatment targets.

The UNAIDS fast track strategy seeks to ensure that 90% of HIV-positive people know their status, 90% are able to access antiretroviral treatment (ART), and 90% of those on treatment attain viral suppression, by the year 2020. Studies on treatment expansion in several southern and East African countries provide new insights on how to achieve the 90-90-90 objectives, while also identifying critical obstacles to overcome.

Anton Pozniak, clinical service director of the HIV unit at the Chelsea and Westminster Hospital in London and treasurer of the International AIDS Society, highlighted the scope of the task by referring to statistics from the UNAIDS Prevention Gap Report, which estimate that 57% of people living with HIV know their status currently, 46% of all people living with HIV have access to ART, and only 38% of people living with HIV have achieved viral suppression.

“The limited success of efforts to provide broader access to treatment are reflected in unacceptable mortality rates and a decreasing momentum in the reduction of new HIV infections globally,” said Pozniak. “The research reported here offers valuable insight into the opportunities and the challenges we face in gearing up delivery systems to meet our HIV treatment goals.”

Two studies presented focus on the impact of the ‘test and treat’ approach to ARV therapy on expanding treatment access and improving retention in care. Under the test and treat model, the administration of ARVs begins as soon as possible after individuals learn they are HIV-positive, without regard to CD4 counts.

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“Interim results from the SEARCH study, conducted in 164 communities in rural Kenya and Uganda, showed a significant advance toward achieving the UNAIDS 90-90-90 target among adults living with HIV,” said Maya L. Petersen, associate professor of Biostatistics and Epidemiology, Berkeley School of Public Health. “The study employed a community-based multi-disease approach to HIV testing combined with a patient-centered ‘test and treat’ model of ART. At the start of SEARCH, 45% of the HIV-positive population had viral loads below 500 copies/ml. Two years later, following the study intervention, 81% were virally suppressed.”

In contrast, a study in 22 rural South African communities found little difference in viral suppression between those offered therapy through the test and treat approach, and those provided with standard ART according to national guidelines. Nine of 10 patients in both groups achieved viral suppression. But the study identified a weakness in the middle of the 90-90-90 cascade – only one in three individuals newly diagnosed as HIV-positive was linked to treatment clinics within six months of testing.

The challenge of ensuring linkage to care after HIV testing was addressed in another study, conducted in Swaziland. A combination of interventions – such as CD4 count testing immediately after receipt of HIV test results, use of mobile phones to remind patients of their appointments, and non-cash financial incentives – resulted in a 50% increase in prompt linkage to care and retention in the treatment program.

Two studies presented at the 2016 International AIDS Conference in Durban, South Africa highlighted commonly-encountered challenges for treatment programs in developing countries:

  • The high proportion of people with HIV who seek treatment at an advanced stageof infection, when the immune system is severely affected and the risk of mortality is high.
  • A growing number of adolescentswho have been on ART for prolonged periods and show declining viral suppression.
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The REALITY trial, spanning Kenya, Malawi, Uganda, and Zimbabwe, compared mortality rates when two different models of care were provided to adults and children who presented for ART with severely compromised immunity (CD4<100 cells/mm³). Half the group (899 people) were provided the standard level of care, including ARVs and the antibiotic cotrimoxazole. The other half (906 people) received the standard treatment plus enhanced prophylaxis for bacterial infections, tuberculosis, cryptococcal meningitis, oral/oesophageal candida, and parasitic worms.

REALITY demonstrated that enhanced prophylaxis saved lives. In the first 24 weeks of treatment, there were 108 deaths in the group receiving standard care, compared to 80 among those receiving enhanced prophylaxis. Within 48 weeks the respective figures increased to 127 and 98 deaths, respectively.

“Providing enhanced prophylaxis at the start of ART reduced early mortality by 25% among patients with advanced HIV disease,” said James Hakim, professor of medicine at the University of Zimbabwe College of Health Sciences. “When the gains are spread across the entire treatment program, we are looking at saving three lives for every 100 patients we treat. Policy-makers should consider introducing this low-cost broad infection package for all HIV-positive patients presenting with very low CD4 counts.”

Researchers analyzing records from South Africa’s National Health Laboratory Service (NHLS) found that the number of children and adolescents receiving ART in the country increased tenfold between 2004 and 2011, and twentyfold between 2012 and 2014, leading to the existence of a ‘youth treatment bulge’. The bulge is mainly due to historic deficiencies in the prevention of mother-to-child transmission of HIV in the country, which resulted in substantial numbers of babies being born with HIV, but surviving due to ART. Now that PMTCT is universally available in South Africa, the bulge is expected to shrink over the coming decade.

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The study also found that viral suppression among young people decreased with age. While 71% of children aged five to nine years were virally suppressed, the rate among those aged 10 to 14 years dropped to 65%, and only 61% of those in the 15-19-year age group achieved viral suppression.

“The number of adolescents accessing HIV care is increasing, yet this group experiences poorer treatment outcomes than other age groups,” said Mhairi Maskew, senior researcher in the Health Economics and Epidemiology Research Office, Faculty of Health Sciences at Wits University. “Programs prioritizing this key population require investment at the national level.”

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Implementing rules and regulations of new HIV Law signed

The new law provides for the lowering of age of consent from 18 to 15 years old. This law also ensures the development of program for treatment, care and support for persons confined in closed-setting institutions. It likewise provides stiffer penalties for breaching confidentiality with regards to ones’ HIV status.

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The Implementing rules and regulations (IRR) of Republic Act 11166, otherwise known as the Philippine HIV and AIDS Policy Act, which eyes to address the growing HIV epidemic in the country, has been signed. The new law repealed RA 8504.

“We are confident that the new law will forge a stronger alliance among government, private sector, civil society organizations, faith-based organizations, media and all stakeholders in order for us to overcome the HIV epidemic,” Health Secretary Francisco T. Duque III said.

It should be noted that in 2008, an average of one infection per day was recorded. This has now ballooned to 36 new infections per day as of April 2019.

“We should act now as fast as we can since 29% (240/840) of all new confirmed HIV cases last April 2019 affect our youth aged 15-24 years old,” Duque said.

In order to address the worsening situation, the new law provides for the lowering of age of consent from 18 to 15 years old. The law specifically provides for intervention through the matured minor doctrine and the provision of proxy consent for children below 15 years old.

The education component of the program was also strengthened by mandating learning institutions to focus not only on the right information on HIV and AIDS but also in human rights principles to reduce stigma and discrimination. HIV education will also cover Indigenous Peoples (IP) communities and communities in the geographically isolated and disadvantaged areas (GIDA).

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A “Comprehensive Intervention” shall be provided to the key affected population which includes males having sex with males (MSM), sex workers, people who inject drugs (PWID), transgender people, and overseas Filipino workers (OFW). The law also provides care and support to all people living with HIV (PLHIV), their affected families and especially the orphaned children.

This law also ensures the development of program for treatment, care and support for persons confined in jails, rehabilitation centers and other closed-setting institutions. It likewise provides stiffer penalties for breaching confidentiality with regards to ones’ HIV status, and much higher liability for those who have access to this information.

No PLHIV shall be denied or deprived of private health insurance under a Health Maintenance Organization (HMO) and private life insurance coverage under a life insurance company on the basis of a person’s HIV status.

“The active involvement of all HIV and AIDS stakeholders will be the key element for the success in the implementation of this new law in achieving the overall health of the PLHIV Communities. This law ensures the effective implementation of our country response to HIV and AIDS through the Philippine National AIDS Council,” Duque concluded.

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Two new algorithms can identify patients at risk of HIV

The final risk prediction model included such variables as sex, race, living in a neighborhood with high HIV incidence, use of medications for erectile dysfunction, and sexually-transmitted infection (STI) testing and positivity.

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Two new studies developed algorithms that can identify patients who are at risk of acquiring HIV and may benefit from preventive care. Both studies appear in the July issue of The Lancet HIV.

Preexposure prophylaxis (PrEP) is an antiretroviral pill that is over 90% effective in preventing HIV acquisition when taken as prescribed. PrEP was recently given a Grade A recommendation from the U.S. Preventive Services Task Force but is vastly underutilized. There are nearly 40,000 new HIV infections annually in the United States, yet the Centers for Disease Control and Prevention estimates that only 7% of the 1.1 million individuals at substantial risk for HIV infection used the antiretroviral pill in 2016.

One barrier to use is the difficulty for providers in identifying patients who are at high risk of HIV acquisition. Providers often have limited time, may have limited knowledge about PrEP, and may lack training in how to talk to patients about sex or substance use. Risk prediction tools, a form of electronic clinical decision support using the data in patients’ electronic health records (EHRs), are often used in other areas of medicine. Researchers from both studies, one using a patient population in California and the other in Massachusetts, built HIV risk prediction models that could be used in EHRs as automated screening tools for PrEP.

The two studies looked back at the medical records of millions of patients who were HIV-uninfected and had not yet used PrEP. Researchers extracted demographic and clinical data from these patients’ EHRs on numerous potential predictors of HIV risk. A machine-learning algorithm automatically selected important HIV risk-related variables for the final models.

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In the California-based study, which used medical record data of 3.7 million patients at Kaiser Permanente Northern California, the final risk prediction model included such variables as sex, race, living in a neighborhood with high HIV incidence, use of medications for erectile dysfunction, and sexually-transmitted infection (STI) testing and positivity. The model flagged 2% of the general patient population as potential PrEP candidates and identified 46% of male HIV cases, but none among females.

“Although risk prediction tools are imperfect and cannot replace the clinical judgement of skilled providers, our algorithms can help prompt discussions about PrEP with the patients who are most likely to benefit from it,” said Julia Marcus, PhD, MPH, lead author of the California-based study and Assistant Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School.

The Massachusetts-based study used a patient population of 1.1 million patients at Atrius Health as well as the population of Fenway Health, an independent community health center in Boston specializing in sexual health care, to test performance in a new setting with higher rates of new HIV infection. The final risk prediction model included sex, race, primary language, as well as diagnoses, tests, or prescriptions for STIs. The model flagged 1.8% of the general patient population at Atrius Health and 15.3% of the population at Fenway Health as potential PrEP candidates. The model also identified 37.5% of new HIV cases at Atrius Health and 46.3% at Fenway Health.

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According to Douglas Krakower, MD, lead author of the Massachusetts-based study and Assistant Professor at Beth Israel Deaconess Medical Center, the Harvard Pilgrim Health Care Institute, and Harvard Medical School, “integrating these prediction models into primary care with routine, comprehensive HIV risk assessments by clinicians could play an important role in increasing the prescription of PrEP and preventing new HIV infections.”

Jonathan Volk, MD, senior author of the California-based study and an infectious disease physician at Kaiser Permanente San Francisco Medical Center added that “a recent publication by the U.S. Preventive Services Task Force in JAMA cites the lack of effective prediction models as a major gap in research that is critical to improving PrEP delivery. Our model helps fill that gap.”

The California study, titled “Use of electronic health record data and machine learning to identify potential candidates for HIV preexposure prophylaxis: a modelling study”, is co-authored by investigators from: Harvard Pilgrim Health Care Institute, Kaiser Permanente Division of Research, Beth Israel Deaconess Medical Center, and Kaiser Permanente San Francisco Medical Center. The project was supported by the Kaiser Permanente Northern California Community Benefit Research Program, the National Institute of Allergy and Infectious Diseases, and the National Institute of Mental Health.

The Massachusetts study, titled “Development and validation of an automated HIV prediction algorithm to identify candidates for preexposure prophylaxis”, is co-authored by investigators from: Beth Israel Deaconess Medical Center, Harvard Pilgrim Health Care Institute, Massachusetts Department of Public Health, Boston Medical Center, Atrius Health, New England Quality Care Alliance, Brown University, The Fenway Institute, and Brigham and Women’s Hospital. The project was supported by the National Institute of Mental Health, Harvard University Center for AIDS Research, Providence/Boston Center for AIDS Research, Rhode Island IDeA-CTR, and the US Centers for Disease Control and Prevention through the STD Surveillance Network.

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Greater prevalence of anal cancer precursors for women living with HIV than prior reports

The results call for new strategies to be developed for wider screening of women living with HIV, who have disproportionally higher rates of anal cancer compared to the general population of women.

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The prevalence of anal high-grade squamous intraepithelial lesions (HSIL), which precede anal cancer, is much higher in women living with HIV than previously reported, a multi-site, national study involving hundreds of patients has found.

Conducted by researchers from the AIDS Malignancy Consortium, a National Cancer Institute-supported clinical trials group, the results call for new strategies to be developed for wider screening of women living with HIV, who have disproportionally higher rates of anal cancer compared to the general population of women. The study appears in Clinical Infectious Diseases.

To determine the true prevalence of anal HSIL in women living with HIV in the United States, the researchers, for the first time, conducted a full anal evaluation including a high resolution anoscopy (an examination of the anus under magnification) with directed biopsy on all 256 female study participants, not just on those who had an abnormal screening test or triage. The prevalence of anal HSIL was 27 percent, substantially higher than previous study estimates, which ranged between four to nine percent.

“We believe most prior studies of anal HSIL prevalence in women living with HIV under-represented the true percentage because only individuals with abnormal anal cytology underwent high resolution anoscopy in past studies, compared to all the participants in this new study,” said Dr. Elizabeth Chiao, the co-author and principal investigator of the study. Dr. Chiao is a professor of medicine in the section of infectious diseases at Baylor College of Medicine and with the Houston VA Center for Innovations in Quality, Effectiveness and Safety.

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The study was conducted at 12 academic medical centers across the United States, with the participants recruited between 2014 and 2016. The mean age of participants was 49.4 years, 64 percent were non-Hispanic black, and 67 percent were former or current smokers.

“The high prevalence of anal cancer precursors and invasive anal cancer among women living with HIV calls for greater screening in this population,” said lead author Elizabeth Stier, MD, of Boston Medical Center, who is also an associate professor of obstetrics and gynecology at Boston University School of Medicine. “Because optimal screening strategies are still not yet known, prevention of anal cancer among this population should focus on identifying cost-effective strategies for the detection and management of anal cancer precursors.”

Screening women living with HIV for anal cancer has been recommended by national organizations, including the American Cancer Society, the Infectious Diseases Society of America, and the American Society of Colon and Rectal Surgeons.

The study was supported by the National Cancer Institute at the National Institutes of Health.

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54% of April’s HIV cases from 25-34 age group; and 29% are 15-24 years old at time of testing

Sexual contact remained as the predominant mode of transmission (98%, 819). Among the newly diagnosed, 57% (475) reported transmission through male to male sex, 24% (203) through sex with both males and females, and 17% (141) were through male to female sex.

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Younger people continue to be the most affected by HIV in the Philippines, with the median age of those newly infected in April 2019 27 years old (age range: 2-73 years old). More than half of the new HIV cases (52%, 434) were 25-34 years old, and 29% (240) were 15-24 years old at the time of testing.

In April, there were 38 newly diagnosed adolescents 10-19 years old at the time of diagnosis. Further, two cases were 17 years old and 36 cases were 18-19 years old. Almost all (95%) were infected through sexual contact (six male-female sex, 19 male-male sex, and 11 had sex with both males and females), one was infected through sharing of needles and one had no data on mode of transmission.

There were three diagnosed cases less than 10 years old and all were infected through vertical transmission (formerly, mother-to-child transmission).

This is according to the latest report from the HIV/AIDS & ART Registry of the Philippines (HARP), which cited that 840 Filipinos were newly infected for the fourth month of the year. Ninety-four percent (789) of the newly diagnosed were male.

Almost a third (32%, 271) were from the National Capital Region (NCR). Region 4A (16%, 137), Region 3 (11%, 92), Region 7 (8%, 65), and Region 6 (7%, 55) comprised the top five regions with the most number of newly diagnosed cases for the month, together accounting for 74% of the total.

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Sexual contact remained as the predominant mode of transmission (98%, 819). Among the newly diagnosed, 57% (475) reported transmission through male to male sex, 24% (203) through sex with both males and females, and 17% (141) were through male to female sex.

Still in April 2019, 14% (114) of the newly diagnosed engaged in transactional sex. Ninety-eight percent (112) were male and aged from 17 to 62 years old (median: 28 years). Forty-six percent (52) of the males reported paying for sex only, 38% (42) reported accepting payment for sex only and 16% (18) engaged in both. Also, among the two female cases who engaged in transactional sex, one was reported to have accepted payment for sex and one had engaged in both.

People who engage in transactional sex are those who reported that they either pay for sex, regularly accept payment for sex, or do both. Reporting of transactional sex was included in the HARP starting December 2012.

Other modes of transmission were sharing of infected needles (1%, 5) and vertical transmission, with <1%, 3). There were 13 cases that had no data on mode of transmission.

Among the newly diagnosed females in April, four were pregnant at the time of diagnosis. Two cases were from Region 4A and one case each from Regions 1 & 10.

Reporting of pregnancy status at the time of testing was included in the HARP from the year 2011.

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In April 2019, there were 752 patients who were initiated on ART. The median CD4 of these patients upon enrollment was 204 cells/mm3. As of end-April 2019, a total of 37,091 PLHIVs were already on ART.

There were 189 reported deaths due to any cause among PLHIVs. Ninety-five percent (179) were males. Thirty-one (16%) cases were 15-24 years old at the time of death, 97 (51%) were 25-34 years old, 52 (28%) were 35-49 years and nine (5%) were 50 years and older. Ninety-five percent of the cases were reported to have acquired the infection through sexual contact: 31 through male-female sex, 92 through male-male sex, and 57 through males who have sex with both males and females. Four (2%) were infected through sharing of needles and one (1%) was through mother-to-child transmission. There were four (2%) reported deaths that had no data on mode of transmission.

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HMOs ordered to provide medical coverage to people with HIV… with limitations

HMOs are expected to provide coverage to PLHIVs under the following conditions: he/she is undergoing proper medical treatment; he/she has a favorable risk profile; and the results of the medical examinations required by the HMO are within normal limits.

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The Insurance Commission (IC) has ordered health maintenance organizations (HMOs) to provide medical coverage to people living with HIV (PLHIVs), as contained in Circular Letter No. 2019-30, issued by Insurance Commissioner Dennis B. Funa on June 21.

The document is in line with Republic Act (RA) No. 11166, or the Philippine HIV and AIDS Policy Act, signed by President Rodrigo Duterte in December 2018.

Under the circular, the IC will implement and develop policies that will ensure compliance with Section 42 of RA 11166, which states that no person/s living with HIV “shall be denied or deprived of private health insurance under an HMO on the basis of a person’s HIV status.”

Section 49 of the law also prohibits “denial of health services, or being charged with a higher fee, on the basis of actual, perceived or suspected HIV status.”

HMOs are expected to provide coverage to PLHIVs under the following conditions: he/she is undergoing proper medical treatment; he/she has a favorable risk profile; and the results of the medical examinations required by the HMO are within normal limits.

But the IC circular isn’t completely PLHIV-friendly.

Notably, HMO applicants may still be required to undergo HIV testing “based on parameters such as, but not limited to, age, total amount at risk, and occupation/lifestyle; provided that the applicant voluntarily consents to such testing pursuant to Article IV of RA 11166,” the IC said. This “HIV testing shall be performed by health facilities recognized by the Department of Health and have the capacity to provide services on HIV testing and counseling.”

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Also notably, the insurance regulator allows HMOs to temporarily suspend or decline the application of PLHIVs who has other medical conditions or other risk factors which would have also resulted in the suspension or denial of the application even if not HIV positive. These include kidney, liver or cardiovascular diseases, hepatitis B or C, pulmonary tuberculosis, signs of infections brought on by a weakened immune system, smoking, and injection of illegal drugs.

HMOs are also allowed to set limits of acceptance for PLHIVs depending on their age, payment terms or amount of coverage, upon approval of the IC. And – seemingly negating itself – HMOs may not decline an application solely based on the HIV status of the applicant, but they can still choose to deny coverage of PLHIVs.

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UNAIDS, UNDP call on 48 countries and territories to remove all HIV-related travel restrictions

Out of the 48 countries and territories that maintain restrictions, at least 30 still impose bans on entry or stay and residence based on HIV status and 19 deport non-nationals on the grounds of their HIV status. Other countries and territories may require an HIV test or diagnosis as a requirement for a study, work or entry visa.

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UNAIDS and the United Nations Development Programme (UNDP) are urging countries to keep the promises made in the 2016 United Nations Political Declaration on Ending AIDS to remove all forms of HIV-related travel restrictions. Travel restrictions based on real or perceived HIV status are discriminatory, prevent people from accessing HIV services and propagate stigma and discrimination. Since 2015, four countries have taken steps to lift their HIV-related travel restrictions—Belarus, Lithuania, the Republic of Korea and Uzbekistan.

“Travel restrictions on the basis of HIV status violate human rights and are not effective in achieving the public health goal of preventing HIV transmission,” said Gunilla Carlsson, UNAIDS Executive Director, a.i. “UNAIDS calls on all countries that still have HIV-related travel restrictions to remove them.”

“HIV-related travel restrictions fuel exclusion and intolerance by fostering the dangerous and false idea that people on the move spread disease,” said Mandeep Dhaliwal, Director of UNDP’s HIV, Health and Development Group. “The 2018 Supplement of the Global Commission on HIV and the Law was unequivocal in its findings that these policies are counterproductive to effective AIDS responses.”

Out of the 48 countries and territories that maintain restrictions, at least 30 still impose bans on entry or stay and residence based on HIV status and 19 deport non-nationals on the grounds of their HIV status. Other countries and territories may require an HIV test or diagnosis as a requirement for a study, work or entry visa. The majority of countries that retain travel restrictions are in the Middle East and North Africa, but many countries in Asia and the Pacific and eastern Europe and central Asia also impose restrictions.

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“HIV-related travel restrictions violate human rights and stimulate stigma and discrimination. They do not decrease the transmission of HIV and are based on moralistic notions of people living with HIV and key populations. It is truly incomprehensible that HIV-related entry and residency restrictions still exist,” said Rico Gustav, Executive Director of the Global Network of People Living with HIV.

The Human Rights Council, meeting in Geneva, Switzerland, this week for its 41st session, has consistently drawn the attention of the international community to, and raised awareness on, the importance of promoting human rights in the response to HIV, most recently in its 5 July 2018 resolution on human rights in the context of HIV.

“Policies requiring compulsory tests for HIV to impose travel restrictions are not based on scientific evidence, are harmful to the enjoyment of human rights and perpetuate discrimination and stigma,” said Dainius Pūras, Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of health. “They are a direct barrier to accessing health care and therefore ineffective in terms of public health. I call on states to abolish discriminatory policies that require mandatory testing and impose travel restrictions based on HIV status.”

The new data compiled by UNAIDS include for the first time an analysis of the kinds of travel restrictions imposed by countries and territories and include cases in which people are forced to take a test to renew a residency permit. The data were validated with Member States through their permanent missions to the United Nations.

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UNAIDS and UNDP, as the convenor of the Joint Programme’s work on human rights, stigma and discrimination, are continuing to work with partners, governments and civil society organizations to change all laws that restrict travel based on HIV status as part of the Global Partnership for Action to Eliminate all Forms of HIV-Related Stigma and Discrimination [hyperlink]. This is a partnership of United Nations Member States, United Nations entities, civil society and the private and academic sectors for catalysing efforts in countries to implement and scale up programmes and improve shared responsibility and accountability for ending HIV-related stigma and discrimination.

The 48 countries and territories that still have some form of HIV related travel restriction are: Angola, Aruba, Australia, Azerbaijan, Bahrain, Belize, Bosnia and Herzegovina, Brunei Darussalam, Cayman Islands, Cook Islands, Cuba, Dominican Republic, Egypt, Indonesia, Iraq, Israel, Jordan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Malaysia, Maldives, Marshall Islands, Mauritius, New Zealand, Oman, Palau, Papua New Guinea, Paraguay, Qatar, Russian Federation, Saint Kitts and Nevis, Samoa, Saudi Arabia, Saint Vincent and the Grenadines, Singapore, Solomon Islands, Sudan, Syrian Arab Republic, Tonga, Tunisia, Turkmenistan, Turks and Caicos, Tuvalu, Ukraine, United Arab Emirates and Yemen.

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