Oral PrEP Access to Trial Participants: Opinions of Community Stakeholders at HPRU, SAMRC Trial Sites


By: Neetha S. Morar, Ishina Hemchund, Nokulunga Bhengu, Prof. Gita Ramjee, HPRU- SAMRC, Durban, South Africa

Background

In November 2017, the South African Medical Research Council (SAMRC) held a summit to discuss the standard of care in prevention and treatment trials in Southern Africa. The summit concluded that the SAMRC and the Fred Hutchinson Cancer Research Center (FHCRC, home of the HIV Vaccine Trials Network (HVTN)) will establish a fund to cover the cost of Truvada for oral Pre-Exposure Prophylaxis (oral PrEP) and HIV testing for HIV prevention trial participants for the duration of the HVTN 702 and HVTN 705 trials [Gray G, Executive Summary of the Summit on the Standard of Care in Clinical Trials in Low-Middle Income Settings, 06 November 2017]. Trial sites and their communities will decide how to provide oral PrEP at each site, and this will likely look different at different sites.

Prof. Gita Ramjee, Director, and Clinical Trials Unit (CTU) Principal Investigator (PI) of the HIV Prevention Research Unit (HPRU) of the SAMRC, held an Imbizo (Zulu term for a gathering or forum) on 08 December 2017 with stakeholders, community working group members (CWGs), peer educators and research team members of HPRU. The event guest speaker included the Deputy Director of HIV/AIDS, STIs and TB (HAST) from the Provincial Department of Health (PDOH). Prof. Ramjee highlighted the HIV epidemic in Sub-Saharan Africa and explained the need for additional HIV prevention methods. There were 7.1 million people living with HIV in South Africa (SA) in 2016. There were 240,000 new HIV infections and 110,000 people died from AIDS-related causes that year [http://www.unaids.org/en/regionscountries/countries/southafrica]. Young women are most affected by HIV. Data on men are still being collected in terms of new infection rates. SA has the highest number of people on ARVs, over 3,000,000 people where 56% are female. 54% of HIV infected children are on treatment. The problem is not getting people on treatment but to keep them on treatment. More HIV-positive people need to be retained in care so that they can achieve suppression of their viral load. Treating and looking after people living with HIV is critical, but it is also important that those who are negative must stay negative. Many people do not like using condoms. Medical Male Circumcision (MMC) is available for men, but few options are available for women. Licensure for a vaginal ring containing ARVs to use for prevention is pending. Additional options for HIV prevention continue to be important.

Objective

The objective of the Imbizo was to discuss the potential access to oral PrEP by trial participants, and gather the opinions of key stakeholders. There was interactive discussion regarding PrEP as an additional tool for HIV prevention among trial participants and the community.

Participants

49 people were invited including partners from the provincial hospitals [where HPRU has a Memorandum of Agreement (MOA)], Community Working Group (CWG) members, stakeholders and peer educators. 25 partners attended as follows:

Representation No. Invited No. Attended
MOA partners 9 1
CWG Members 26 18
Stakeholders 9 3
Peer Educators 5 3
Researchers 29 21
Total 78 46

Discussion

The Director of HPRU gave an overview of all the HIV Prevention research conducted by HPRU and gave an update about Truvada as Oral PrEP. Oral PrEP is not for everyone, since it must be taken orally daily. It must be used consistently daily for 20 days to achieve adequate tissue protection levels for vaginal protection, and 7 days for anal protection, prior to sexual exposure. Oral PrEP does not prevent sexually transmitted infections (STIs) nor does it have any contraceptive properties. Dr. Simone Hendricks, a clinical doctor from HPRU, explained the clinical considerations, the eligibility criteria, indications, contraindications and side effects of using Truvada as oral PrEP. There were concerns about drug resistance. Prof. Ramjee explained that the risk of drug resistance is very low in HIV negative people using oral PrEP. Drug resistance is more likely to occur in a person who is already HIV-positive and is on ARV treatment. It is therefore important for a person who is on oral PrEP to have regular HIV tests. If a person becomes HIV positive, oral PrEP is immediately stopped and ARV treatment is initiated. To date there have been no issues with resistance post-seroconversion. The DoH is monitoring the issue of drug resistance.


“I will say I am very happy that the Universities were considered as one of the first people to access PrEP. As communities, we must be able to reiterate the message of HIV to the community. Coming together is the beginning, working together is a progress.”

- Imbizo Attendee


Stakeholders agreed that oral PrEP should be available for clinical trial participants while they are in the trial. However, after the trial, participants will need to access oral PrEP via demonstration projects or at private healthcare providers and SAMRC will assist with referrals as necessary. There is no visit reimbursement for participants who attend the clinic only to access oral PrEP. They must be made aware of this and that it is a service HPRU, SAMRC will provide based on their individual requests.

Mukelisiwe Mlotshwa, Deputy Director from HIV/AIDS, STIs and TB (HAST) Unit of the Kwa-Zulu Natal Department of Health shared the plan to rollout oral PrEP to the public in a stepwise process. They have started oral PrEP access with men who have sex with men (MSM), commercial sex workers (CSW), and recently university students. One of the stakeholders expressed their excitement about the government’s decision to make oral PrEP available for young people as they are at high risk of HIV acquisition. The Minister of Health, Dr Aaron Motsoaledi is committed to making oral PrEP available to everyone eventually. The community stakeholders understood that this is a slow process, and they were made aware of the costs and resources needed to roll out oral PrEP.


“I’m happy that there is someone from DoH here, we have faith that things will happens going forward, and I’m optimistic that it will be a fruitful initiative. The government took long to provide ARVs I am requesting that PrEP can be rolled out sooner.”

- Imbizo Attendee


All stakeholders at the meeting appreciated the opportunity they had to discuss oral PrEP and valued the new information they received. Many expressed their eagerness to share oral PrEP information with their families, communities and organizations.

The steps in prioritizing PrEP access was also discussed with the group. It was clarified that access to specific populations was based on the high HIV incidence and prevalence rates among high risk groups. Service providers are also exploring options of where oral PrEP may be offered and overtime access to oral PrEP may be available in the health clinics within the public sector.  The process of monitoring and evaluating oral PrEP access, use and adherence is key to its effectiveness, as a person may get infected with HIV while on oral PrEP is he/she is not adherent.

Recommendation from Community Stakeholders and Partners

The community stakeholders agreed that clinical trial participants should be provided with oral PrEP for the duration of the trial, thereby affording them the highest standard of care available. However, they emphasized that the trial participants need to be adequately educated about oral PrEP so that they can make an informed decision about whether they wish to access oral PrEP. Most community stakeholders believed the packaging of oral PrEP (bottle) is not user friendly as people may think it is ARVs for treatment, thus, contributing to stigma against those who are living with HIV.  They proposed that pill boxes may be a more user-friendly alternative to bottles.  The attendees gained very useful information from the workshop. They recommended that HPRU train the CWGs on oral PrEP as they need to be educated since they are the heart and soul of the community. They need training to assist in educating communities and addressing myths and misconceptions about oral PrEP.

Way Forward

The community stakeholders valued the information and knowledge they gained from the workshop on oral PrEP. However, they urged the Department of Health to increase efforts to educate the community about oral PrEP as this may improve acceptability and use of the HIV prevention option. While oral PrEP was accepted as a potential HIV prevention method, community stakeholders supported the researcher’s efforts to explore new interventions such and infusions of antibodies. For current and new HIV prevention methods to be used, there is a need to have support of the community which is also important to achieve research outcomes.

Neetha Morar is the Research and Community Manager, Ishina is the Research Assistant,
Nokulunga Bhengu is the Community Liaison Officer, and Professor Gita Ramjee is the
CTU Principal Investigator of the HPRU in Durban, South Africa.