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December 2017
Dear Reader,
Welcome to the last edition of the ECHO Update for 2017! It’s been an exciting year for the ECHO Study, as we’ve reached important milestones and continue to learn valuable lessons through the follow-up phase. Please read on and we hope you enjoy!

Study Progress

Data and Safety Monitoring Board recommends ECHO Study continue

Clinical staff
The ECHO Study’s independent Data and Safety Monitoring Board (DSMB) met on Wednesday, 15 November 2017, for its fourth scheduled meeting since study initiation. The review focused on the study data, safety, the conduct of the study and its anticipated timeline over the next year. 

The DSMB members commended the study leadership, the data centre, all the investigators and teams, and the participants for the conduct of the study, concluding that ECHO remains highly relevant and is being well-conducted. They recommended that the study continue without modification.
 

ECHO Study celebrates two year anniversary

On 14 December 2017, the ECHO Study celebrated its two-year anniversary. The first participants were enrolled in the study at MatCH Commercial City and Wits RHI in December 2015. Nearly two years later, the study reached its ambitious enrolment target. The study officially closed enrolment on 12 September 2017 with a total of 7,830 participants at its 12 sites across South Africa, Kenya, Swaziland and Zambia. Since then, sites have shifted their focus from recruitment to retention efforts by continuing to monitor retention rates, intensifying their retention strategies and preparing for community dialogues to facilitate ongoing discussions with stakeholders, especially as the study prepares for dissemination of study results. Results are expected in 2019.
 


Best Practice: Male Partner Involvement

Aside from condoms, use of modern contraception overall remains a woman’s responsibility. Still, men’s understanding of contraception, from the options available to possible side effects and benefits, can greatly facilitate women’s acceptance and ability to continue using methods. 

For one ECHO Site, they are committed to improving men’s support of women in the ECHO study by tackling the issue on two fronts. Based in Edendale, the Maternal Adolescent and Child Health (MatCH) Research site and its staff have embarked on a series of activities that either directly or indirectly target male partners of ECHO participants. First, the site has convened ECHO clubs, which is based on a model first developed by the FACTS 001 microbicide trial. The clubs provide a space for participants to come together to share concerns and ask questions. MatCH has used these clubs to allow women to practice communication skills and discuss ways to safely disclose their study participation in ECHO to their male partners. 

MatCH Edendale has also run a series of dialogues on contraceptive issues, where both male partners and men throughout the community, have been invited to learn about contraception and the study. The dialogues have provided important opportunities for men to share their beliefs and discuss how their attitudes may influence women’s use of contraception. They also focused on improving people’s understanding of how clinical research in general works. Addressing research literacy helps men appreciate what participation in the ECHO Study involves and dispels myths about study participation. The aim is facilitate male partners supporting women’s ongoing participation, or at minimum, not interfering or “disapproving” of their involvement in ECHO.   
The dialogues have revealed important lessons, including: 
  • Men had different attitudes, beliefs and opinions on who should decide on which contraceptive method to use. Some men felt they should be involved in this decision, while others felt women should decide for themselves. 
  • Barriers towards male involvement include perceptions that reproductive health is a woman’s domain due to gender norms and because traditional family planning communication is geared towards women, perceived side effects of female contraceptive methods and limited choices of available male contraceptives.
  • Some men noted that their female partners do not share information about contraceptives with them. 
Research shows that effective communication between partners can serve as an enabler towards effective contraceptive use. However, few reproductive health programmes are designed to address the barriers to male engagement that was identified in the dialogues at MatCH Edendale. Since the initiation of its male engagement activities, MatCH Edendale has documented less method discontinuation and less switching of randomised methods among participants. The discussions are working, both between the couples and with the communities at large.


Site Profile

FLAS/ICAP

MatCH Research CCC
Recruitment and Retention officer – Zonkhe Tembe speaks to women at a clinic in Manzini. Photo Samkelo Dladla, FLAS/ICAP.

The FLAS/ICAP ECHO Site, located in Manzini, Swaziland, is a collaboration between the Family Life Association of Swaziland (FLAS) and ICAP. FLAS is a Swazi non-governmental organisation that has been championing access to quality, rights-based, gender-equitable, youth-focused and non-discriminatory sexual and reproductive health information and services. ICAP is a global leader in public health founded at Columbia University in 2003 to support research and programmes to improve the health of families and communities.

How many participants did you enrol for the ECHO Study?
The FLAS/ICAP ECHO Study site was activated on 19 September 2016, and we have since enrolled 502 participants. Despite being the last site activated, we managed to reach our enrolment target within a year. Participants were recruited from several sites in Manzini, including FLAS static clinics and neighbouring clinics, public health units and hospitals, non-governmental organisations and community-based organisations.

What have been your initial lessons learned so far? 
Through the ECHO Study we have become more aware of the needs of women for contraceptive information and the need to provide a wide mix of methods that women can choose from. We have identified how many myths and misconceptions about the study products have arisen amongst community members. We have noticed that women do not have access to up-to-date, quality information on contraceptives. For instance, many women in our community still believe that contraceptives can only be used by women who have been previously pregnant. 

We have also learnt that standardising the information disseminated to service providers and their clients on contraceptives is equally important. 

The ECHO Study is the first ever clinical trial for Swaziland. Can you tell us about your experience? 
We received overwhelming support from our stakeholders, including the Ministry of Health, nearby health facilities, internal review boards (IRBs), our community advisory committee, universities, and community-based organisations. 

Furthermore, we were pleasantly surprised by our rapid enrolment curve and being amongst the ECHO sites that met their enrolment targets. We were also surprised by the high number of women who showed interest in joining the ECHO Study despite being required to be randomised to one of the three study products.     

To what do you attribute your success thus far?
We attribute our success to our hard-working team who go out of their way to care for our participants and make them feel special. We also have maintained good working relationships with our stakeholders, both local and international.

What are the main questions the community is asking about ECHO?
We are frequently asked if the contraceptive method they receive will prevent them from being infected with HIV and whether or not they can stop using the contraceptive method they have been assigned at any time.

To the first question we respond by saying that none of the methods offered in the ECHO Study are known to reduce the risk of HIV infection. The most effective way to protect against HIV during sex is to use a condom every time they have sex. We will provide free condoms.

To the second question we respond by saying yes, they can stop using their assigned method at any time and that they should let us know if they wish to do so. We tell them that if they were assigned the copper IUD or Jadelle, then one of our doctors or nurses will safely remove it for them. In the case of Depo-Provera, we remind them that its effects last for about 3 months after their last injection. We also inform them that if they stop using an assigned method, it is important that they still come to the site for their study visits and provide us with information about their new method and sexual behaviour.

We would like to thank Samkelo Dladla, Study Coordinator, and the entire FLAS/ICAP team for their dedication to this important study and their contributions to this article.
 


Good Participatory Practices (GPP)

Community outreach


ECHO site teams continue to engage in community outreach activities. Here are a few highlights from World Aids Day:
 
Emavundleni site team celebrate World AIDS Day. Photo credit: Siyabonga Ngqame, Emavundleni Research Centre
The UNC Kamwala site team set up an exhibition stand during World AIDS Day celebrations. Photo credit: Modesta Chileshe, UNC Kamwala Clinic.
Emavundleni community members participate in World AIDS Day activities. Photo credit: Siyabonga Ngqame, Emavundleni Research Centre.


Upcoming Events

HC3
12 - 16 Feb - 8th African Conference of Sexual and Reproductive Health

4 - 7 March - Conference on Retroviruses and Opportunistic Infections (CROI) 


23-27 July – 22nd International AIDS Conference (AIDS 2018)

Thank you for reading this edition of the ECHO Update


A special thanks goes to the site staff at MatCH Research – Edendale, FLAS/ICAP, Emavundleni Research Centre and UNC Kamwala for their contributions to this issue.

We encourage you to give us feedback and share requests for stories and information you would like to see featured in future editions.

Don’t forget to visit our website at http://echo-consortium.com for more information about the ECHO Study.

Thank you for your support in 2017. We wish you an enjoyable festive season and we look forward to another exciting year in 2018.
 
ECHO Study team

 






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ECHO Comms Team · 22 Esselen Street · Hillbrow · Johannesburg, Gauteng 2001 · South Africa

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