Media Release FOR IMMEDIATE RELEASE

 

Media Release

FOR IMMEDIATE RELEASE

Largest ever whole-of-population study on the impact of TB and HIV interventions on the burden of TB launched in sub-Saharan African communities

Friday, 23 March 2018 (London, UK) – A new EUR 12.9 million project has been launched, measuring the impact of a combination TB and HIV intervention when delivered to the entire population of 14 urban, high-prevalence communities in South Africa and Zambia.

TB and HIV are the leading infectious causes of death worldwide – in 2016 1.7 million people died of TB. For people living with HIV, TB is the most significant co-infection, 40 percent of HIV deaths in 2016 were due to TB. The TREATS project [Tuberculosis Reduction through Expanded Anti-retroviral Treatment and Screening] was developed in response to this.

“TREATS is a unique opportunity to assess a combined TB and HIV intervention on a massive scale,” said Dr Helen Ayles, TREATS Project Director, Professor of Infectious Diseases at London School of Hygiene & Tropical Medicine and Research Director at Zambart. “It will provide amazing data and hopefully some practical solutions to end TB. TB is a curable illness, but in order to better reach people with treatment, we need to understand the epidemiology of the disease better. This is true active case-finding.”

TREATS aims to inform new policies and approaches for tackling the TB / HIV epidemic. As the global health community works towards ambitious new goals to end TB, TREATS will provide invaluable new information for accelerating effective interventions.

TREATS is being conducted by a consortium of organisations that is already running the largest ever trial of a combination HIV prevention strategy, known as HPTN 071 (PopART). This trial is being conducted across 21 communities in Zambia and South Africa, covering around one million people in total. PopART involves universal testing and treatment for HIV through house-to-house visits on an annual basis over four years – from 2014 – 2018. As part of PopART, all community members are also screened for TB.

Building on PopART, TREATS will measure the impact of this combined TB / HIV intervention on tuberculosis – measuring prevalence of disease as well as incidence of infection. The project runs until 2021 and includes: a social science component to better understand stigma related to TB; mathematical and economic modelling to provide answers for how future large-scale interventions can be undertaken effectively; use of the newest tools available for diagnosing TB infection and operating effectively on a large scale.

TREATS consortium members include: London School of Hygiene &Tropical Medicine, Imperial College London, Zambart, KNCV Tuberculosis Foundation, Sheffield University, the International Union Against Tuberculosis and Lung Disease (The Union), Health Systems Trust, Delft Imaging Systems and QIAGEN.

The EUR 12.9 million project is part of the European & Developing Countries Clinical Trials Partnership, (EDCTP2 programme) supported by the European Union under Horizon 2020 – its Framework Programme for Research and Innovation.

 

#worldTBday

#TREATSproject

 

ENDS

Further information:

Johanna Dollerson
The Union
jdollerson@theunion.org
+44 7920 421783

Helen Platt
The Union
hplatt@theunion.org
+44 7487 268167

Zambian Government Welcomes Adolescent HIV Prevention Study Findings

As the HIV epidemic continues to take its toll on Zambia, a new HIV prevention study on young people has found that most Zambian adolescents are HIV negative, but more needs to be done to keep them negative by increasing their access to treatment and prevention programmes. This gives hope to researchers, policy makers and government actors that the tide can be reversed against new HIV infections.

Results released by researchers of the PopART for Youth Study (P-ART-Y) in Lusaka on March 15, 2018 indicated that more youth-oriented treatment services are needed to strengthen retention of HIV positive adolescents and youth in care. The study researchers said adequate resource allocation is required towards school-based Comprehensive Sexual Education because schools are a primary source of HIV information for young people. Legal barriers hindering adolescents from receiving HIV testing services and other sexual and reproductive health services need to be addressed, in addition to creating more youth safe spaces within the communities.

Health is about the communities that we serve. We must take our services to the communities to prevent disease.- Dr Abel Kabalo, Director of Health Promotions, Environment and Social Determinants, MOH.

P-ART-Y researchers made public these findings and other lessons learned during the study intervention at a national level dissemination event that brought together senior government health officials and representatives of  various health agencies, local and international researchers, policy makers,  implementing partners in HIV treatment and prevention,  action groups and youth representatives.

Zambian Minister of Health Dr Chitalu Chilufya in his formal address presented on his behalf to the gathering by Ministry of Health Director of Health Promotions, Environment and Social Determinants Dr Abel Kabalo, said P-ART-Y was in line with the government strategic direction to focus on adolescent and youth in HIV treatment and prevention. He said through the 2014-2016 National HIV/AIDS Strategic Plan, government has identified young people as key in the fight against HIV and will prioritise its interventions towards them.

Dr Chitalu Chilufya applauded the research and said to win the fight against new HIV infections key vulnerable populations must be involved. “Adolescents are a key tool in winning the battle against HIV, and the findings of this research feed into the government plan for HIV prevention.”

He said the government will make decisions based on evidence that show impact so that valuable resources are not wasted in combating the AIDS epidemic in Zambia. “This study is no mean achievement. PopART is unique in design and implementation, and the government is delighted to work with local researchers and will continue to support them,” Dr Chilufya said.

Dr Chilufya said Zambia has made strides in combating new HIV infections with robust HIV targets and strategies. He said the President’s declaration on routine HIV testing, the government’s change of HIV

treatment guidelines to include universal testing and adopting of viral load testing to monitor treatment are a demonstration of the government’s will  to achieving the 90, 90, 90 UNAIDS treatment strategy to end AIDS by 2020. “We’re changing treatment guidelines and viral load testing to monitor HIV, and we are improving funding to fight HIV through the introduction of the new national health Insurance Bill,” he said.

P-ART-Y was a two-country ancillary study nested within the on-going HPTN 071 (PopART) Trial, and funded by the UK Department for International Development (DFiD) through Evidence for HIV Prevention in Southern Africa (EHPSA).  The research was conducted by a consortium of Zambian and international researchers in close collaboration with the Ministry of Health in 21 high-density communities in Zambia and South Africa. Of these communities, 12 were in Zambia spread across 7 districts in 4 provinces (Copperbelt, Central, Lusaka, and Southern Provinces).

The objective of P-ARTY study was to evaluate the acceptability and uptake of a community level combination HIV prevention package that included a universal test and treat among adolescents and young people aged 10 to 24 years in both countries, with a focus on the 15 – 19 year old group. The study also compared the knowledge of HIV status in the standard of care communities.

P-ART-Y study results come just months ahead of the main landmark HPTN 071 (PopART) trial which is measuring the impact of a combined HIV prevention package on community level HIV incidence, and ends in June 2018. The final results of the PopART trial will be available early 2019.

P-ART-Y Study Manager Dr Joseph Mwate said what the study had achieved has never been done before. “We tested a very huge number of adolescents in one setting. Over 150, 000 young people in Zambia alone,” he said.

Dr Mwate said that P-ART-Y achieved the first 90 target, “This is first step to reaching an AIDS free generation,” he said and added that the study also significantly closed the gap in the second 90 HIV which set Zambia on correct path to the 2020 AIDS goal.

The HPTN 071 (PopART) study under which P-ART-Y was nested is the single largest HIV prevention trial to be ever conducted with partners in 3 continents. It is taking place in Zambia and South Africa and represents a population of 1.2 million people.

Differences in health-related quality of life between HIV-positive and HIV-negative people in Zambia and South Africa…

Ranjeeta Thomas, Ronelle Burger, Abigail Harper, Sarah Kanema, Lawrence Mwenge, Nosivuyile Vanqa, Nomtha Bell-Mandla, Peter C Smith,
Sian Floyd, Peter Bock, Helen Ayles, Nulda Beyers, Deborah Donnell, Sarah Fidler, Richard Hayes, Katharina Hauck, on behalf of the HPTN 071 (PopART) Study Team*
Summary
Background The life expectancy of HIV-positive individuals receiving antiretroviral therapy (ART) is approaching that of HIV-negative people. However, little is known about how these populations compare in terms of health-related quality of life (HRQoL). We aimed to compare HRQoL between HIV-positive and HIV-negative people in Zambia and South Africa. Read full article.

Community Engagement Award

The HIV Prevention Trials Network (HPTN) 2017 annual meeting brought together researchers from its clinical trials involved in HIV prevention in countries across the world. Zambart, is part of a consortium of international researchers currently conducting the world’s largest HIV prevention trial in 21 communities in Zambia and South Africa.

The Zambart Community Engagement (CE) team on the HPTN 071(PopART) Trial won the Best Community Engagement Award for outstanding performance in mobilising the biggest community randomised HIV prevention study in the world. During the course of the four year study, Zambart’s CE team has developed novel strategies to engage, sustain, and work together with other study groups to increase participants for the trial, including ancillary studies nested with the main trial.

PopART Study Staff Reflections, Challenges, and Experiences

Reflections on 2017 PopART Study all-staff training & retreat

During the last PopART study all-staff training the various teams had an opportunity to share their personal experiences and reflects about the trial. The field teams, on whom the successful implementation of the study relies heavily, had some great feedback about PopART. Equally the supervisors and technical leaders who support the field teams and enable them to boldly carry out their work had a few things to say.

Here are just a few examples of some of the PopART staff reflections from the field and head office alike:

“When you change a life, you change a life forever,” – Steve Belemu, Zambart Community Engagement Team

“The HPTN 071 is an extraordinary study, and we did it, each and every one of you.” – Dr Helen Ayles, PopART Site Principal Investigator: Z Director of Research- Zambart

“PopART has been an amazing study. It has successfully managed to mobilise efforts of different people, organisations and communities towards the dream of achieving an HIV free Zambia. Yes, it is possible to get rid of HIV if we replicate PopART at country level.” – Dr Musonda Simwinga, Zambart Community Engagement Lead & Social Scientist

“I first became involved in HIV research in 1985. The lab I was in was among those conducting the initial trials of AZT, which became the first drug approved for treatment of individuals infected with HIV. Three decades later, PopART is demonstrating the efficacy of treatment as prevention at the population level. It’s gratifying to be a part of the PopART team and the remarkable advances that have been made in HIV treatment.” – Barry Kosloff, Head of Zambart Laboratories

“One day we went in the field and enrolled a female participant whose husband had died some years before. She wanted to know her HIV status. The research assistant consenting the woman and I was called to collect the sample. After the test was done, she was found to be reactive and we linked her to care. She then asked if I could also test her daughter who was not looking too healthy and she also tested reactive. We linked her to care too. From that time to date, this family is like my family to me. I feel happy when I pass by their home and see how happy they are and getting on with their life.” (PopART CHiP)

“I tested a man in a household that I had been visiting in my zone, he tested HIV positive but it was very difficult to link him to care. When he fell very ill, that is when he started the treatment and he is now doing fine. And after that, his mother disclosed that she was also taking care of a child who lost its mother at a very young age. I probed more and asked if I could test the child. The test was positive and I managed to link the child to care. The child looks good and feels good now. She doesn’t get sick like before. This makes me happy and am proud of myself at least I have saved a life.” (CHiP)

In other bizarre experiences shared by the PopART intervention team staff: A female CHiP reflected how a client insisted to the PopART team visiting his household that he was born naturally circumcised and attempted to show them. And in another instance, a client attempted to remove all his clothes off to show the CHiP team during a household visit a skin rash that had spread all over his body.  Some of the CHiPs narrated how at the beginning of the study they would sometimes be mistaken for political cadres. Another CHiP recalled a field encounter when instead of conducting HCT they found themselves as first responders to an expectant woman’s call for help and helped to conduct a home delivery, after which they assisted the woman to the health facility for onward care.

“In year one we tested the wife in absence of the husband and the results were negative. Shortly afterward, the husband came and the wife asked the husband to also test but with a warning that if her results came out positive that would be the end of their marriage. Later, the wife left the house to go to the market and the husband asked to be tested in the absence of the wife and he tested HIV positive.

In year two, we went back to the household and tested the wife again. She tested positive. But she could not understand how she could be positive when her husband was negative (the husband had told her that he tested negative when in actual fact he was positive). The wife refused to start treatment fearing the husband who thought she was negative. The husband-had refused to start treatment for fear of being divorced by the wife who he believes was negative.”-  (CHiP)

“In annual round two, I went to a household where I tested a seven (7) year old girl and she was reactive. Unfortunately, she was not linked to care because her father’s family said that she was too young to be HIV positive, and the girl’s mother’s relatives insisted her mother died of witchcraft and not HIV. In annual round three, I learned that they had not yet linked her to care because of the misunderstanding and beliefs from the two families. This matter was reported to the supervisor and the youth counsellor but to no avail. Eventually the girl got very ill and that is when they cousin decided to take her to the clinic. The file was opened for the girl. As I.mm writing, the girl’s condition has improved.”(CHiP)

“A 13 year old client told me that he was denied condoms, so he only picks the used condoms, washes them and then use them. The CHiP advised him not to pick used condoms because they are contaminated. He was counselled on abstinence ad tested for HIV and condoms were given to him.”- (CHiP)

In delivering the house-to-house PopART HIV prevention package in the various study communities, the field teams comprised of Community HIV Care Providers (CHiPs); Research  Assistants; Research Nurses; Community Mobilisers; worked in collaboration with community leaders and health facilities. Over the course of the four years of study implementation, PopART staff forged great friendships and further strengthened the nearly 3 decade old partnership Zambart has had with the communities.

Thanks to everyone for their support, dedication, and teamwork that continues to make Zambart a solid community-focused local research organization working to improve health for all Zambians.

 

Clinical Performance Study field visit by the Principal Investigator

Principal Investigator, for the Self-Testing Africa Project (STAR) Dr Helen Ayles, on June 8 2016, joined the Clinical Performance Study (CPS) team in M’tendere Township, in Lusaka, one of the study sites of the project. The two-year programme funded by UNITAID to provide cost-effective solutions for expanding existing HIV testing services, is being conducted in Zambia, Malawi, and Zimbabwe.

Dr Ayles, who is the Zambart Research Director, wanted to get a hands-on view of how the Clinical Performance Study is being carried out and to learn some of the field challenges staff are experiencing. She also observed how participants conduct the self-test using the provided OraQuick® HIV self-test kit, and how they read and record their own results.

The study will determine whether oral fluid HIV self-tests can be used effectively and read accurately across different populations in Zambia. The study will compare the results of oral fluid tests with a laboratory-based blood test to determine the sensitivity and specificity (ability of the test to pick out true positives as positives (Sensitivity), and to pick out only the HIV anti-bodies specifically (Specificity). Further, CPS aims at establishing the accuracy of the HIV self-test when used by intended users, who include: adolescents and adults in urban and rural Zambian settings.

Captured in the picture above, Dr Alyes, looks on as a CPS Research Assistant, Debbie Sibayuni, enters data into an Electronic Data Capturing device, collected from a study participant in Kalikiliki area, a densely populated compound on the outskirts of M’tendere community. The client is asked questions about the self-test after she performed an HIV self-test using OraQuick®.

2OraQuick® is being piloted in M’tendere and Kanakantmpa communities in Lusaka and Chongwe districts respectively, to determine the acceptability of HIV self-testing. Self-testing can help to reach those who are unable to access HCT services because of various social, cultural and geographical challenges, and encourage re-testing among those at high-risk. It can also help to reach those unlikely to use current HIV testing services because of privacy issues or lack of convenience.

Zambart has engaged with a consortium of researchers and implementers to provide research expertise in Zambia for the use of HIV self-tests in populations with the greatest need. The consortium is led by Population Services International (PSI) led collaboration, which includes the Ministry of Health, and Society for Family Health as the main distributors of the OraQuick HIV Self-Test kits. Other partners ion the STAR project are the London School of Hygiene and Tropical Medicine (LSHTM), the Liverpool School of Tropical Medicine (LSTM), University College London, and the World Health Organisation (WHO), and the Ministry of Health.

Zambart public engagement project: Nzuna lulila ya sugar

For the last few years we have been working on some research projects that have focused on how diabetes affects tuberculosis in Lusaka (The DARTZ studies). Through this work we have met many people who are living with diabetes and we have listened to their stories. We have heard story after story about the difficulties and barriers that individuals living with diabetes face in Lusaka. Stories of years of multiple visits to clinics with diabetes symptoms before a diagnosis is made. Stories of young people with severe complications because they haven’t been able to access adequate treatment. And we have seen patients die in their twenties and thirties from uncontrolled, untreated diabetes; deaths that could have been prevented with long-term adequate treatment. Tuberculosis has a structured and coordinated service for diagnosis and treatment that exists throughout the country, but diabetes lacks even basic national guidelines for its management. We therefore wanted to help to raise the profile of diabetes and decided to do this through the use of cartoons.

IMG_5724

We invited some people living with diabetes to join a small workshop. Six participants attended. During the workshop we discussed the difficulties and challenges that result from living with diabetes. The main challenges that emerged during the workshop were accessing care at the clinic, accessing appropriate food products and accessing accurate information about diabetes. We invited a cartoonist, Kiss Brian Abraham, to observe the workshop and draw some cartoon pictures based on the discussions throughout the workshop and with the involvement of the workshop participants. We then used the cartoon pictures to inform the wider public about diabetes and raise the profile of some of the challenges facing people living with diabetes. We hope that this will help to provoke solutions to be found for these challenges and ultimately help to improve the lives of people living with diabetes in Lusaka.

The cartoon pictures can be seen in the accompanying leaflet.

DARTZ1 DARTZ2 DARTZ3

Adolescents in the PopART Trial

Uptake and acceptability of a combination HIV prevention package among young people in Zambia and South Africa:

A new ancillary study to be nested in the HPTN 071/PopART trial, and whose aim is to evaluate the acceptability and uptake of a community-level combination HIV prevention package that includes Universal HIV Testing and Treatment (UTT) among adolescents has started.
The inclusion of adolescents in the HPTN071/PopART study was approved by the ethics committee on 14th September 2015 and study started end of October, 2015. The study, mostly funded by the United Kingdom government’s Department for International Development (DFID), Norwegian Agency for Development (NORAD), and Sweden, will be a community randomized comparison of a combination prevention approach, combined with youth targeted interventions.
The Adolescents in PopART study will provide process data on the uptake of HIV testing and linkage to HIV prevention and care by adolescents aged 15-20 years old, and is expected to provide evidence on the acceptability and uptake of HIV combination prevention packages including Universal Test and Treat in young people. It also provides an opportunity to add and evaluate youth specific interventions for prevention and care.
sam_9428Previously, there was no specific adolescent focus in the PopART trial, and all impact measures occurred in adults aged 18-44 years only. However, the Adolescents in PopART study, will address the unique needs of this key population as it presents an opportunity to assess whether a population-level strategy of combination HIV prevention including universal HIV testing and treatment is effective in reaching adolescents. The findings from the study are expected to have policy and practice implications within the Southern Africa region and beyond.
The Adolescents in PopART study is being carried out by a consortium of partners: Zambart; Desmond Tutu TB Centre, Stellenbosch University, South Africa; London School of Hygiene and Tropical Medicine; and Imperial College, London. The study will be nested within all the 21 PopART study communities in Zambia (12 sites) and South Africa (9 sites).
Following regulatory approval of the study, re-orientation was rolled out in October 2015 across all intervention sites, in addition to prior training of all study staff in May 2015, in Livingstone on how adolescents will be incorporated into the intervention activities of the trial.  Dr Joseph Chaila, the study manager explained that the adolescent study has since been activated in all the sites and will run for 26 months.
Kelvin Phiri, a CHiP from Kabwe said-“Adolescents have been disadvantaged in terms of access to HTC in the past and the door- to door approach may be one way to offer this service although our counselling skills are already been “challenged” in a positive way”.
“Adolescent inclusion in the study is good because in the first year we were just referring children to the facility for counselling and testing and parents were reluctant to take children, especially when the child was not sick; this time the service is delivered at their door step” said Osborn Mashawira CHiP supervisor from Kabwe.

HPTN 071/PopART Site Monitoring Visit

An HPTN 071 team was in Zambia recently to conduct a site monitoring visit of some of the PopART study sites. Sara Fidley of the London School of Hygiene and Tropical Medicine (LSHTM), and Sam Griffith and Ayana Moore of FHI 360 in the United States, arrived in Zambia on November 2-6, 2015. Accompanying them were Zambart Research Director and PopART Site Principal Investigator Dr Helen Ayles, and Study manager Dr Kwame Shanaube.

The monitors’ first port of call was the tourist capital Livingstone where for the next two days they would meet with the intervention teams, conduct field visits and on-site inspections at the Dambwa and Maramba PopART site offices.

The team proceeded to the capital Lusaka where they split into two groups with Mr Griffith going to visit Kanyama site, and Ayana and Sara going to Chipata site. Here they were accompanied by the site study leadership, managers, and site supervisors. In Chipata their focus was on the Population Cohort, but had time to interact with the medical staff at Chipata first level hospital who included the Medical doctor in charge of the hospital, and the ART-sister in Charge, in addition to the rest of the PopART staff. The team also managed to accompany the PC nurses in the field.

Sam Griffith accompanied by the Intervention team from head office, toured Kanyama site. In addition to accompanying the CHiPs in the field, he also received an update from site staff on various activities carried out including inspection of registers at the PopART Information Desk. Implementing partners from CIDRZ were also available to provide additional updates.

Their last visit was Makululu site in Kabwe where they noted a marked improvement in the various intervention activities, particularly in HIV, Counselling and Testing (HCT), and that CHiPs were paying more attention to detail.

PopART Enrolls Populations With Disabilities

Makululu Enrols Special Population Groups in PopART Study

In a bid to scale up linkage to care and Universal Test and Treat, the Kabwe PopART intervention team at Makululu site have begun to enrol individuals from special population groups.

As the Community HIV Care Providers (CHiPs) go about their intensified field activities to engage more men and strengthen linkage to care of clients, they have increasingly encountered people with physical disabilities, particularly the hearing and speech impaired in need of the PopART intervention services.

While this initially presented a new challenge for the teams, they quickly overcame it and have since mobilised themselves, partnered with a qualified sign-language interpreter and are constantly on the lookout for special population groups within Makululu community.

Because the numbers of individuals from special populations groups have been steadily increasing, the PopART team, working with the interpreter, has been prompted to conduct special orientation sessions for the members of groups they have encountered on basic HIV transmission, prevention and treatment methods.

Over 10 couples have so far been enrolled, and all of them on ART.