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Does timing matter for initiating HIV therapy in infants?

The success of attaining and sustaining viral suppression was similar in the 46 infants starting ART less than two days old (51 percent) and the 27 infants starting therapy between 2 and 14 days after birth (54 percent).

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Starting HIV antiretroviral therapy (ART) within hours of birth has been hypothesized to have positive effects raising the possibility of remission in some children with HIV. To test the hypothesis, researchers at Columbia Mailman School of Public Health and Columbia University Irving Medical Center designed a trial in a group of newborns with HIV who started ART within 14 days of birth.

The results showed that about 75 percent of infants attained viral suppression on ART; but only 52 percent attained and sustained viral suppression on ART. The success of attaining and sustaining viral suppression was similar in the 46 infants starting ART less than two days old (51 percent) and the 27 infants starting therapy between 2 and 14 days after birth (54 percent). The findings are published online in E-Clinical Medicine.

“The results of our trial suggest that very early treatment in newborns may not have to mean within hours of birth,” said Louise Kuhn, PhD, Columbia Mailman School professor of epidemiology (in the Sergievsky Center). “We learned that we must be more attune to basing decisions about how quickly to start ART on optimizing maternal adherence with treatment rather than with just focusing on speed. While we certainly do not want to introduce undue delay, starting ART within the first two weeks of life led to similar outcomes to starting within the first two days of life.”

The study was designed shortly after the report of the infant in Mississippi who started antiretroviral treatment within 30 hours of birth and who was able to maintain viral suppression off treatment for over two years. This case report led to optimism that ART started within hours of birth may lead to protection of critical immune processes and smaller viral amounts, making possible remission in a sizable minority of infants treated in this way. “The outcome in Mississippi raised the tantalizing possibility that we may be able to facilitate remission in infants if we start ART very early in life,” noted Kuhn.

To yield the target population for the trial, clinical protocols were established at Rahima Moosa Mother and Child Hospital (RMMCH), Johannesburg, South Africa. The analysis included 73 children who were born between March 1, 2015 and September 30, 2017 with confirmed HIV infection and ART initiated within 14 days. The initial ART regimen consisted of nevirapine, lamivudine and zidovudine; nevirapine was replaced with lopinavir-ritonavir once the child reached 42 weeks post-menstrual age, usually about 4 weeks of age in calendar time. ART was initiated based on results of the first round of diagnostic testing and was continued throughout the study.

Of those surviving during the study, 75 percent attained viral load <50 copies/ml on ART but not all of these sustained this low level of virus. Dividing the group into the 46 infants who started ART less than two days old and the 27 infants starting ART between 2 and 14 days old, showed a similar percent achieving and sustaining viral load <50 copies/ml on ART. In the very early treated infants (less than 2 days old), 51 percent achieved and sustained viral suppression; in the early treated infants (2 to 14 days old), 53 percent achieved and sustained viral suppression.

“Viral suppression rates, especially to more stringent cut-offs than required by our protocol were lower than expected, and we concluded that very early ART on its own, with routinely-available regimens, is unlikely to lead to remission in a sizable minority of early-treated infants,” said Kuhn. This is most likely explained by the significant challenges of adequate maternal adherence with ART for neonates and infants including major practical difficulties of sustaining adherence with twice-daily, poorly-palatable liquids for infants. Moreover, most of the study participants’ caregivers live in impoverished economic circumstances with complex social problems and experience a high degree of HIV-related stigma.

“We need to find interventions to treating newborns that are reasonable for mothers to fully adhere to,” said Kuhn. Long-acting formulations and/or alternative interventions may be more adherence-friendly and need to be investigated. These may enable more rapid and sustained viral control and immune recovery in a larger proportion of early treated infants as a stepping stone to achieve remission.

Co-authors are Stephanie Shiau, Elaine Abrams, and Wei-Yann Tsai, Columbia Mailman School; Yanhan Shen, Columbia Sergievsky Center; Renate Strehlau, Faeezah Patel, Karl-Günter Technau, Megan Burke, Gayle Sherman, Ashraf Coovadia, Rahima Moosa Mother and Child Hospital and University of the Witwatersrand, Johannesburg; Grace M. Aldrovandi, UCLA; Rohan Hazra, Eunice Kennedy Shriver National Institute of Child Health and Human Development; and Caroline Tiemessen, National Institute for Communicable Diseases, National Health Laboratory Services, and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

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HIV-1-specific immune cells can recognize viral particles with capacity to rebound following ART interruptions

Majority of these immune cells, called CD8+ T cells, should have the capacity to detect the HIV-infected cells that drive HIV-1 rebound following interruptions to treatment. This insight could contribute to the development of new curative strategies against HIV infection.

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Immune cells that can recognize residual HIV-infected cells in people living with HIV (PLWH) who take antiretroviral therapy (ART) remain active for years, says a study published in eLife.

The findings also suggest the majority of these immune cells, called CD8+ T cells, should have the capacity to detect the HIV-infected cells that drive HIV-1 rebound following interruptions to treatment. This insight could contribute to the development of new curative strategies against HIV infection.

ART has transformed HIV-1 from a fatal disease to a chronic condition in PLWH. However, it must be taken by those with the infection for the rest of their lives, as interrupting treatment often allows the virus to rebound within weeks. This rebound results from cells harbouring HIV-1 DNA that is integrated into the human genome.

“While more than 95% of proviral DNA is unable to replicate and reactivate HIV-1, the remaining fraction that we define in our study as the ‘HIV-1 reservoir’ maintains its ability to produce infectious virus particles and cause viral rebound,” explains lead author Joanna Warren, Postdoctoral Investigator at the Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, US. “The largest and most well-characterized HIV-1 reservoir resides in ‘resting’ CD4+ T cells, which circulate in the blood and are long-lived.”

T cells likely help to control viral rebound and could be leveraged in future treatment strategies against HIV.

There are a couple of strategies to allow people with HIV-1 to stop ART without viral rebound. Both approaches may harness HIV-1-specific CD8+ T cells to achieve the reduction or elimination of the HIV-1 reservoir. However, variations (or mutations) in viral particles that exist in the HIV-1 reservoir may limit the capacity of these T cells to recognise and clear virus-infected cells, meaning the cells can escape detection and go on to cause viral rebound. “In our study, we wanted to determine the frequency and patterns of T-cell escape mutations in the HIV-1 reservoir of people who are on ART,” Warren says.

To do this, the team measured HIV-1-specific T-cell responses and isolated reservoir virus in 25 PLWH who are on ART. Of these participants, four started on ART during acute HIV-1 infection, which means virus levels were controlled early, while the other 21 started on ART during chronic HIV-1 infection, which means considerable virus mutation occurred before virus levels were controlled.

In the HIV-1 proteome (the entire set of proteins expressed by the virus) for each participant, the team identified T-cell epitopes (regions of proteins that trigger an immune response). They sequenced HIV-1 ‘outgrowth’ viruses from resting CD4+ T cells and tested mutations in T-cell epitopes for their effect on the size of the T-cell response. These strategies revealed that the majority (68%) of T-cell epitopes did not harbor any detectable escape mutations, meaning they could be recognized by circulating T cells.

“Our findings show that the majority of HIV-1-specific T cells in people on ART can detect HIV viruses that have the capacity to rebound following treatment interruption,” concludes senior author Nilu Goonetilleke, a faculty member at the Department of Microbiology and Immunology, University of North Carolina at Chapel Hill. “This suggests that T cells likely help to control viral rebound and could be leveraged in future treatment strategies against HIV.”

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Study links low immunity to poor outcomes in patients with HIV who contract COVID-19

“When we have vaccines, our goal is to identify the most vulnerable populations. Patients with HIV should be a priority target when we are looking at any measure that could improve outcomes for patients at high risk for complications with COVID-19.”

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Clinical trials are testing whether medications that treat human immunodeficiency virus (HIV) can also treat COVID-19, leading some patients with HIV to believe they might be protected against the coronavirus. But a researcher from the MU School of Medicine not only found patients with HIV are susceptible to the virus, she also discovered which factors increased the risk of hospitalization and death.

Principal investigator Dima Dandachi, MD, assistant professor of clinical medicine, examined data that included 286 adult patients with HIV who were diagnosed with COVID-19 across 36 institutions in 21 states. Within 30 days of COVID-19 diagnosis, 57% of the patients required hospitalization, 16% required ICU admission and 9% did not survive. In the study, more than 94% of patients were actively taking HIV medication.

“We were able to show that patients with HIV who are actively taking their medication are just as susceptible to COVID-19 as the general public,” Dandachi said. “And those with low immunity uncontrolled HIV or newly diagnosed HIV are at a higher risk of hospitalization or death. The key message for these patients is to take precautions against contracting the virus while ensuring they are compliant with their HIV medications to raise their immune cell count as high as possible.”

Dandachi and her team of researchers found people with HIV older than 60 and those with chronic health issues also had a much higher risk of being hospitalized or dying from COVID-19.

“The medications that prolong the lives of patients with HIV have improved life expectancy, but now we are seeing these patients develop other chronic conditions such as obesity, diabetes and heart disease that we didn’t see 15 years ago,” Dandachi said. “And when we looked at the data from this study, we found that lung disease, kidney disease, hypertension and older age were associated with higher hospitalization rates, higher ICU admissions and increased mortality from COVID-19.”

As a researcher-clinician who treats patients with HIV, Dandachi will use this study to counsel her patients to best protect themselves against COVID-19 while also using it as proof that this patient population should be among the first considered for protection once a vaccine is developed.

“When we have vaccines, our goal is to identify the most vulnerable populations,” Dandachi said. “Patients with HIV should be a priority target when we are looking at any measure that could improve outcomes for patients at high risk for complications with COVID-19.”

Dandachi’s study, “Characteristics, Comorbidities, and Outcomes in a Multicenter Registry of Patients with HIV and Coronavirus Disease-19,” also featured contributions from Mojgan Golzy, PhD, an assistant research professor in the Department of Health Management and Informatics; and MU School of Medicine students Grant Geiger and Maraya Camazine. It was published by the journal Clinical Infectious Diseases.

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POZ

Study supports WHO recommendation to use dolutegravir as first-line HIV treatment; efavirenz an alternative option

A study supports the current recommendation from the World Health Organization to use dolutegravir as first-line treatment for HIV, with efavirenz as an alternative option. However, the study also suggests that dolutegravir should be combined with TDF/FTC, which is associated with suppression of weight gain.

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A study supports the current recommendation from the World Health Organization to use dolutegravir as first-line treatment for HIV, with efavirenz as an alternative option. However, the study also suggests that dolutegravir should be combined with TDF/FTC, which is associated with suppression of weight gain, and not with the newer combination of TAF/FTC, which is associated with excess weight gain and clinical obesity, especially in women.

For the ADVANCE research study, conducted in central Johannesburg in South Africa, over 1,000 participants were recruited from routine HIV services in and around the inner city area of Hillbrow. Data was cross-analyzed with two of the current Department of Health antiretroviral regimens, recommended in the 2019 ART guidelines, and a third regimen favored by higher-income countries. The newer regimens appeared to have side effect and resistance benefits over older regimens, and potential cost benefits, but little research had been done on non-Western populations with them.

All three regimens were very potent and well tolerated by patients; however, the newer regimens containing dolutegravir (DTG) and tenofovir alafenamide (TAF) demonstrated a large increase in weight, especially in women.

After 96 weeks of treatment, the percentage of people with viral suppression was 79% in the TAF/emtricitabine (FTC)+DTG arm, 78% in the TDF (tenofovir disoproxil fumarate)/FTC+DTG arm and 74% in the TDF/FTC/EFV (efavirenz) arm.

There were no significant differences in overall efficacy between the three treatments tested.

In terms of weight gain, after 96 weeks of treatment, men gained 5.4 kg in the TAF/FTC+DTG arm, 3.6 kg in the TDF/FTC+DTG arm, and 1.1 kg in the TDF/FTC/EFV arm.

For women, at the same time point, the weight gain was 8.1 kg in the TAF/FTC+DTG arm, 4.8 kg in the TDF/FTC+DTG arm, and 3.2 kg in the TDF/FTC/EFV arm.

The treatment emergent obesity for women at week 96 was 28% for those on TAF/FTC+DTG (5% for men), 18% for those on TDF/FTC+DTG (4% for men), and 12% for those on TDF/FTC/EFV (3% for men).

Dr Simiso Sokhela, lead clinician on the study, commented: “We are concerned about the weight gain and body composition changes which are more severe in women, and we have predicted new risk of associated diabetes and other complications, especially when taking both TAF and DTG together. The 96 week results supports the WHO treatment guidelines which reserve TAF only for patients with osteoporosis or impaired renal function.”

The study team suggest that service providers should consider the best options for patients to reduce their risk of long-term co-morbidities, and should consult with patient groups, researchers and other expert groups for guidance.

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POZ

Short-term use of HIV-prevention medication protects at-risk men on vacation

Short-term use of pre-exposure prophylaxis (PrEP) medication could be a highly successful way to prevent the spread of HIV in men who have sex with men and have difficulty with long-term PrEP use. It may also work to transition men to long-term PrEP use, which has been shown to be highly effective in reducing HIV transmission.

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Even if Filipinos still can’t widely access pre-exposure prophylaxis (PrEP)…

Men at particular risk for HIV are very likely to consistently take prevention medication during vacations when their odds of contracting the virus are higher, according to a new study led by scientists at the University of Pittsburgh Graduate School of Public Health, The Fenway Institute and Harvard University.

The findings, published in the Journal of Acquired Immune Deficiency Syndromes, indicate that short-term use of pre-exposure prophylaxis (PrEP) medication could be a highly successful way to prevent the spread of HIV in men who have sex with men and have difficulty with long-term PrEP use. It may also work to transition men to long-term PrEP use, which has been shown to be highly effective in reducing HIV transmission.

“We started this as a feasibility study to see if we could identify barriers to short-term PrEP use and make adjustments. But we were excited when we got the results and discovered that almost all the participants were adherent to the point of protection against HIV,” said lead author James Egan, Ph.D., M.P.H., assistant professor of behavioral and community health sciences at Pitt Public Health. “This gives us a promising strategy to pursue in engaging at-risk men in HIV prevention efforts that work for them.”

When taken as a daily pill, PrEP reduces the risk of getting HIV from sex by about 99%, according to the Centers for Disease Control and Prevention. However, adhering to a daily medication regimen doesn’t work for everyone for reasons that include cost and individual concerns about the biological consequences of long-term medication.

Previous studies have shown that there are certain periods when men who have sex with men are more vulnerable to contracting HIV, including when traveling, on vacation, moving to a new city or after a break-up. Egan and his team set out to explore whether these men might be more receptive to adhering to PrEP treatment during these times.

The team followed 48 adult men from Pittsburgh or Boston who have sex with men in a pilot program to test the daily use of PrEP for 30 days that included an out-of-town vacation, with the men starting the medication seven days before the trip and continuing for at least seven days after vacation. The men were also given a brief session introducing them to the use of PrEP.

After their vacations, 94% of the men had blood concentrations protective against HIV, consistent with regular use of the medication. Almost 75% reported condomless sex during vacation, and about a third reported recreational drug use. None of the men contracted HIV during their vacation, though one of the men contracted the virus during the three-month post-vacation follow-up period when he’d had a lapse in use of PrEP associated with loss of health insurance and a move to a new city.

Additionally, 70% of the participants indicated an interest in continuing daily PrEP use long-term.

“That really stood out to us,” said senior author Kenneth Mayer, M.D., medical research director at The Fenway Institute at Fenway Health in Boston and professor of medicine at Harvard. “It shows us that introducing short-term use of PrEP before a vacation could lead to longer-term use. This presents an enticing opportunity to reduce HIV transmission.”

However, the scientists pointed out, the study included men who were motivated to enroll and did not address the likelihood of physicians prescribing PrEP for short-term use, the ease of obtaining PrEP for use only during vacations or the impact of the study’s brief counseling on the use of PrEP.

“These are all areas that our findings suggest warrant future explorations,” Egan said. “Our study tells us short-term adherence to PrEP during high-risk periods is tolerable in men who have sex with men, and that it could lead to long-term use. Now we need to determine how to make it possible in the real-world setting.”

Additional authors on this research are Ken Ho, M.D., M.P.H., and Ron Stall, Ph.D., M.P.H., of Pitt; Moe T. Drucker, B.S., and Ryan Tappin, N.P., M.P.H., of Fenway Health in Boston; Craig W. Hendrix, M.D., and Mark A. Marzinke, Ph.D., of Johns Hopkins University; Steven A. Safren, Ph.D., of Fenway Health and the University of Miami; Matthew J. Mimiaga, Sc.D., M.P.H., of Fenway Health and Brown University; Cristina Psaros, Ph.D., of Massachusetts General Hospital; and Steven Elsesser, M.D., of Fenway Health and the University of Pennsylvania.

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Health & Wellness

Notable percentage of trans men who have sex with men never got tested for HIV, bacterial and viral STIs

When considering screening for HIV and sexually transmitted infections (STIs), transgender men who have sex with men (TMSM) represent an understudied population. A study found that a notable percentage of TMSM had never tested for HIV and bacterial and viral STIs.

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When considering screening for HIV and sexually transmitted infections (STIs), transgender men who have sex with men (TMSM) represent an understudied population. A study found that a notable percentage of TMSM had never tested for HIV and bacterial and viral STIs.

In “Sociodemographic and behavioural factors associated with testing for HIV and STIs in a US nationwide sample of transgender men who have sex with men” – done by Nadav Antebi-Gruszka, Ali J. Talan, Sari L. Reisner and Jonathon Rendina, and published in BMJ Journals – researchers tried to examine HIV and STI testing prevalence among TMSM along with the factors associated with testing in a diverse sample of TMSM. They used data from a cross-sectional online convenience sample of 192 TMSM, analyzed using multivariable binary logistic regression models to examine the association between sociodemographic and behavioral factors and lifetime testing for HIV, bacterial STIs and viral STIs, as well as past year testing for HIV.

The researchers found that more than two-thirds of TMSM reported lifetime testing for HIV (71.4%), bacterial STIs (66.7%), and viral STIs (70.8%), and 60.9% had received HIV testing in the past year. Engaging in condomless anal sex with a casual partner whose HIV status is different or unknown and having fewer than two casual partners in the past six months were related to lower odds of lifetime HIV, bacterial STI, viral STI and past year HIV testing.

Being younger in age was related to lower probability of testing for HIV, bacterial STIs and viral STIs.

The domiciles of the TMSM also affected their health-seeking behaviors. In this study, those residing in the South of the US were less likely to be tested for HIV and viral STIs in their lifetime, and for HIV in the past year.

Finally, lower odds of lifetime testing for viral STIs was found among TMSM who reported no drug use in the past six months.

According to the researchers, these findings indicate that a notable percentage of TMSM had never tested for HIV and bacterial and viral STIs, though at rates only somewhat lower than among cisgender MSM despite similar patterns of risk behavior.

They recommend for “efforts to increase HIV/STI testing among TMSM, especially among those who engage in condomless anal sex.”

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People You Should Know

Living with HIV in Digos City

Meet Robin Charles O. Ramos, a person living with HIV in Digos City in Davao del Sur. There are numerous challenges there – e.g. they still have to go to Davao City for their laboratory tests, and get monthly supplies of life-saving ARVs. But they are starting to organize so PLHIVs can help each other.

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“We cannot deny the fact that there are people who will really discriminate us (people living with HIV),” said Robin Charles O. Ramos, who is based in Digos City in Davao del Sur in Mindanao, southern Philippines. “(But) think twice… before you discriminate because (everyone can be infected with) HIV.”

BI AWAKENING

Charles, 33, used to be only attracted to girls. But when he was nine years old, “I (was also) attracted to boys. I realized that I am attracted to both sexes.”

Charles’ family teased him for this. But he added that it’s not like they can prevent him from being bisexual; this “runs in the family,” he said, with other family members also LGBTQIA.

“It was somewhat difficult for me to come out,” he said. This is because he lives in a “relatively small community (where people know me).”

Digos, a 2nd class city and the capital of the province of Davao del Sur, has a population of only 169,393 people (in 2015).

But Charles eventually told others, realizing the relevance of being true/honest to oneself. “I know it (may not be easy) but… the community will (eventually) understand who and what we are.”

FINDING OUT ABOUT HIS HIV STATUS

On November 30, 2017, Charles found out he has HIV.

Prior to the diagnosis, he recalled having bad health – e.g. his cough wouldn’t go away, he had lymph nodes in his throat, he easily got tired/stressed out, and he had recurring fever. He self-medicated, “taking paracetamol” and antibiotics.

“I lost a lot of weight,” Charles recalled, “from 56 kilograms to 48 kilograms.”

At that point, his mother told him: “It’s time to rush to the hospital.”

The attending physician had Charles undergo more tests… including HIV antibody test.

The person who gave him the news about his HIV status was “actually a friend of mine.” In fact, he pre-empted the counselor from telling him the result; “I told her myself, ‘It’s positive, right?’.”

EVERYONE CAN BE INFECTED

Even before then, Charles actually worked in HIV advocacy.

So the person who gave him the news about his HIV status was “actually a friend of mine.” In fact, he pre-empted the counselor from telling him the result; “I told her myself, ‘It’s positive, right?’.”

That was also “mind conditioning” for him, he said. “I conditioned my mind that I’m positive already… it’s a way of acceptance of the matter.”

Right there and then, Charles opted to tell family members. And they had one question for him: Why him, considering he’s in HIV advocacy, and should know better?

“Anyone can be infected,” Charles said to them.

“Think twice… before you discriminate because (everyone be infected with) HIV.”

BEING OPEN ABOUT LIVING WITH HIV

If there’s one thing Charles said that’s good about being out, it’s being able to get external help as needed.

“I lose nothing by coming out,” he said. And for him, “PLHIVs need to come out… as a strategy for us to eradicate stigma and discrimination.”

At this stage in his life, “I don’t care if they talk about me. This is already here. Just accept it.”

Charles is also a teacher, and he opted to tell his supervisors and peers about his medical condition. This honesty paid off since “they support me.” His workmates always remind him to “not be stressed” and “have time to rest”.

HIV-RELATED ISSUES IN DAVAO DEL SUR

HIV screening and/or testing is, at least, accessible to the people of Digos City, said Charles. The social hygiene clinic (SHC) of the local government unit (LGU), for one, offers this; and “every time we conduct (gatherings) about HIV, there is HIV testing (given).”

It is the access to life-saving medicines (the antiretroviral treatment, or ARV) that is problematic.

“Here in Digos City, ARV is not yet available,” Charles said.

And so PLHIVs from there have to go to the Southern Philippines Medical Center (SPMC) in Davao City, which is 62.5 kilometers away (or approximately an hour of commute).

If there’s one thing Charles said that’s good about being out, it’s being able to get external help as needed.

Many of the PLHIVs from Digos City go to SPMC together, renting a van to take them to and from Davao City for their regular tests and ARV supplies.

A related issue: PLHIVs have to go every month because they are only given a month’s supply because of procurement issues. The usual practice is to give PLHIVs supply for three months. And – even if the Department of Health denies that there are issues concerning ARV supplies – at least the Digos City experience highlights the continuing difficulty with accessing life-saving medicines.

The dream for PLHIVs like Charles is for a refilling station to be established in Digos City to serve not only those living there, but also the nearby localities of Kidapawan City, Davao Occidental, et cetera.

EMPOWERING THE HIV COMMUNITY

Charles recognizes that many try to help PLHIVs, but he also thinks that empowering PLHIVs to help each other is essential.

“We have formally created a group: Bagani Southern Davao,” he said. The name was derived from the word “Bagani”, the peacekeeping force of the Manobo tribes and other indigenous groups in Mindanao. Akin to the word, “we’re warriors; we’re fighting against this illness.”

There are currently 20 active members; though, of course, not all PLHIVs in the area are members.

The dream for PLHIVs like Charles is for a refilling station to be established in Digos City to serve not only those living there, but also the nearby localities of Kidapawan City, Davao Occidental, et cetera.

To other PLHIVs in the area, Charles said he recognizes that it may take time before they can decide if they’d come out. “I respect (this) decision… But coming out as PLHIV is a way of educating people that they shouldn’t fear us, and that (having HIV) isn’t the end of our lives or the end of anything.”

As PLHIVs, he said, “we have more to offer, more to do” particularly in educating people.

And to non-PLHIVs or those who do not know their HIV status: “Know your status. Get tested. And stop discriminating people. It’s not like we wanted this to happen to us. But this is already here. We just need your support, and the respect that we want because we’re still human beings.”

“I lose nothing by coming out,” he said. And for him, “PLHIVs need to come out… as a strategy for us to eradicate stigma and discrimination.”

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