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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.

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PopART Study holds final all-study training and retreat

On August 8-11, about 700 staff members on the HPTN 071 (PopART) trial in Zambia, gathered in the small resort fishing town of Siavonga, south of the capital Lusaka, for their last annual refresher training and retreat before the end of study intervention activities later in December 2017.   Organizers brought together all the study staff from the 12 PopART sites, including central Zambart office in one place. This was a huge undertaking by the study leadership and Zambart management.

The PopART trial is the world’s largest community randomized HIV prevention study involving an estimated 1.2 million people in 21 large population communities in two Southern African countries: Zambia and South Africa. Since 2013, international and Zambian researchers have been measuring the impact of combined HIV prevention intervention methods including universal testing and treatment and door-to-door HIV Counselling and Testing, and active referral.

 DSCF5668The training included team building sessions. Team leaders and managers mentored Community HIV Care Providers (CHiPs) in delivery of the final study messages to prepare communities for the end of the study, data collection, orientation in HIV Self-testing, and reviewed enrolment of households participating in the study. Population Cohort (PC) and Phylogenetics scientists and technologists reviewed the upcoming final round of PC activities and Xpert Tuberculosis (TB) testing including other laboratory based activities and protocol training. The r Social Science team reviewed stigma tools for the qualitative cohort and activities conducted under the PopART Story of the Trial.

Zambart Chief Executive Officer Dr Alwyn Mwinga commended the PopART study team in Zambia for their dedication to delivering a complex study such as PopART, through the work that they do.

We have achieved what we set out to do. This study must be written up and put in history books because it is such an interesting research,

she said during the formal opening of the training.

DSC01886Site Principal Investigator Dr Helen Ayles said that the PopART trial was an extraordinary study and was by far the biggest study on HIV prevention ever done. She thanked all the study staff for their hard work and dedication,

You have been amazing, and I want to thank you for such a job well done. This is something that can be rolled out at national scale.

Dr Ayles, explained to the study team the forthcoming end of study intervention activities on 31st December, 2017.

“This has always been a study and we have always had a limited life span. You have managed to reach more young people, and more individuals who had previously not tested for HIV,”

she said, and unveiled plans for continued lower level PopART intervention related activities. These included the on-going Community ART, HIV Self-Testing and measuring the prevalence of TB in PopART.

It is going to be different, but there will still be research activities going on in our sites after the PopART intervention end, for example we will also do more work with adolescents and in social science,”

Dr Ayles said.

 DSC03304Trainers used the opportunity of having everyone together to reflect on the various challenges, experiences and lessons learned by the different study teams during the course of the trial. This generated a deep introspective discussion and brought out poignant aspects of the trial.  This was colorfully depicted through the building of the gigantic PopART study reflection tree. This was a hands-on and exciting time for all study staff. The study teams received awards in various categories and concluded the training on a high note in select sporting activities such as soccer, volley ball and boat cruises on Lake Kariba.

Helen Ayles presenting at IAS 2017. Photo by Roger Pebody, aidsmap.com

Dr Ayles on the HIV Self Testing at the IAS Paris Conference

courtesy of aidsmap.

Adding HIV self-testing as an additional option to a door-to-door programme offering HIV testing in Zambia boosted the uptake of HIV testing among men, younger adults and those who had previously refused HIV testing, Helen Ayles of the London School of Hygiene and Tropical Medicine told the 9th International AIDS Society Conference on HIV Science (IAS 2017) in Paris today. It appears that HIV self-testing may have a particular impact on testing rates in men and could contribute to meeting the 90-90-90 targets in men.

Ayles emphasised that the effect was seen in communities which had already been exposed to three years of intensive efforts to offer HIV testing to all. People who had not already been tested must be considered the ‘hardest to reach’ and the self-testing intervention was notable for having an impact with these individuals.

The study presented was a substudy of PopART (also known as HPTN 071), a large community-randomised trial being carried out in high-prevalence communities in Zambia and South Africa. PopART is aiming to implement an approach of universal HIV testing and universal access to immediate HIV treatment for those who need it, in order to reduce new HIV infections.

The main approach to HIV testing used in PopART is home based HIV testing, in which lay counsellors (known in the study as Community HIV Care Providers or CHiPs) systematically visit all households in a geographical area and offer HIV testing and counselling. While this approach is feasible and acceptable, it is challenging to achieve very high levels of uptake among men, younger people and mobile individuals (for example, people travelling for work).

By the end of the second year of PopART, the target of having tested 90% of people had been achieved for women, in almost all age groups over 20 years (but not for younger women). But uptake was much lower in men – in most age groups, between 70 and 85% had tested, with uptake only surpassing 90% in those over the age of 55.

Supplementary approaches appear to be necessary.

A substudy of PopART therefore aimed to evaluate whether offering self-testing as an additional option would increase the uptake of HIV testing. This was a cluster-randomised trial in 66 zones in four communities in Zambia. In the 33 intervention zones, household members were offered two options for HIV testing – rapid testing by the lay counsellor or self-testing. In the 33 zones in the control group, only rapid testing by the lay counsellor was offered.

The standard PopART intervention, offered in the control group, involves lay counsellors making door-to-door visits to households and offering rapid HIV testing, using a finger prick blood test. The lay counsellors also test for sexually transmitted infections and tuberculosis, as well as promoting and making referrals to treatment and male circumcision services. They also provide support for retention in care and adherence to treatment.

In the arm of the study in which self-testing was an option, it was chosen by 55% of those who took a test. The vast majority (88%) of those taking a self-test chose to have the lay counsellor present during the test, described as ‘supervised’ self-testing by the researchers. The health worker could help with problems users faced in operating the test or in interpreting the result. Helen Ayles said that she would expect more self-testing to be unsupervised in the future, as people become more familiar with the process.

Another testing modality was ‘secondary distribution’ — when a household member was absent, a self-testing kit could be left with their partner for them to use later.

By the end of a three-month period earlier this year, 60.4% of adult men in the intervention arm knew their HIV status, compared to 55.1% in the control arm. A similar effect was not seen in women.

The effect of providing self-testing was also seen in people of both genders aged 16 to 29 (73.5% in the intervention arm and 70.2% in the control arm knew their status).

There was also strong evidence that providing self-testing improved knowledge of status in individuals who were locally resident during earlier phases of PopART but had previously turned down the offer of testing by the PopART lay counsellors. Among these individuals, 29.7% knew their status in the intervention arm, compared to 20.6% in the control arm.

In the control arm, 2.6% of people testing had reactive results. The figure was similar for people tested by the lay counsellor in the intervention arm (2.5%), people using self-tests with supervision (2.9%) and people using self-tests without supervision (3.5%).

However, it was noticeable that in people tested following secondary distribution (i.e. partners who were absent when the lay counsellor visited), the numbers with reactive results were higher. In 81 people who discussed their results with the lay counsellor, 9.9% had a reactive result and in 242 people whose results were communicated by the partner to the lay counsellor, 5.4% had a reactive result. Secondary distribution may be particularly helpful in reducing undiagnosed infection. In many cases, it led to the couple testing together.

Qualitative findings from in-depth interviews and focus groups suggested that self-testing was acceptable for people who were worried about waiting times and stigma in clinics; self-testing had advantages in terms of confidentiality, control and convenience; and that people felt empowered by knowing how to test themselves. Self-testing was particularly acceptable for busy and mobile people, married men, those living with a partner, people of higher social classes, those in formal employment and members of key populations (such as sex workers).

Helen Ayles said that HIV self testing is a solution for engaging ‘hard-to-reach’ groups such as working men and mobile populations with HIV testing. She said that even if the increase in testing uptake may be modest (a few percentage points), this should be considered in the context of a population that has already been given multiple opportunities to test.

Read the full article on www.aidsmap.com

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Q&A with Dr. Virginia Bond

Martha Henry, Executive Director of HAI, spoke over Skype with Dr. Bond in Zambia.

What is your research process for the social science aspects of PopART?

I work with a core team. We have Zambian and South African social scientists who we’ve recruited and done a lot of training with. In the sites where we’re doing interventions, we have local social science research assistants who are residents of that place. When we go to those communities, we work with them. READ MORE…

 

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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.

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HIV self-testing study staff receive orientation

The Self-Testing Africa(STAR) Study is a three-country research namely: Malawi, Zambia and Zimbabwe, and is funded by UNITAID. In Zambia the study partners are Society for Family Health (SFH), Population Service International (PSI), Zambart, London School of Hygiene and Tropical Medicine (LSHTM), and Liverpool School of Tropical Medicine (LSTM).

The aim of the study is to catalyse the HIV Self-Testing market in Malawi, Zambia and Zimbabwe by testing innovative market interventions and strengthening evidence base around the effective use of HIV rapid diagnostic tests (HIV-RDT), through formative and evaluative research. The primary objective is to increase the uptake of quality assured HIV Self-Testing among the general urban and rural population.

On April 7-8, 2016, Zambart held a 2-day orientation for STAR study staff aimed at equipping the Research Nurses and Research Assistants on Good Clinical Practice in Research and the steps to follow when recruiting participants for the Oral HIV Self-testing using Ora Quick HIV Testing Kits.

Zambart is conducting the clinical performance study in Lusaka at Mtendere Clinic, and in Chongwe district in Kanakantapa community. This will be done over a 12-month period. Meanwhile, the impact assessment of the STAR study will be conducted in 4 centres in Kapiri Mposhi (central Zambia) namely: Chankomo; Nkole; St. Pauls, and NCDMS. In Ndola (Copperbelt) at Lubuto and Twapya clinics; in Lusaka at Ngombe and Bauleni clinics, and in Choma (southern Zambia) at Mbabala, Mapanza, Sikalongo, and Batoka clinics.

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World TB Day 2016

On March 24, 2016, Zambart joined the rest of the country in commemorating World TB Day. Across different study sites in Lusaka, Copperbelt and Southern provinces, Zambart staff under the on-going HPTN 071 (PopART) study engaged in different awareness – raising activities in the local communities.

PopART-ART-Interevntion-ManagerPopART study Community HIV Care Providers (CHiPs) distributed condoms, conducted TB screening and sputum collection, community HIV Counselling and Testing (HCT) mostly targeted at adolescents and men.  They also sensitised the communities on TB stigma, TB management, infection control and prevention.

Tents were mounted in select areas where CHiPs were positioned to specifically target the youth and adolescents.

Group-Education-on-TB-in-the-Community-on-WTDTB Corner staff and Community Advisory Board Members (CAB), PopART study implementing partners and district health staff in some study sties, joined the CHiPs in the community awareness-rising campaigns.

Zambart staff took the lead and screened for TB first as well breaking down barriers by submitting sputum for examination.

Communities in all the PopART study intervention sites were involved in the World TB day commemorative activities. These include: Chimwemwe and Ndeke in Kitwe; Chifubu in Ndola; Makululu in Kabwe, Kanyama and Chipata in Lusaka, and Maramba and Dambwa in Livingstone.