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BACKGROUND - PowerPoint PPT Presentation

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472. METHODS. RESULTS. BACKGROUND. Access to care by seroconvertors: MDP 301 Trial.

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Access to care by seroconvertors: MDP 301 Trial

The HIV Prevention Research Unit (HPRU) of the Medical Research Council conducts research focusing mainly on female controlled HIV prevention options. Over the past 7 years the HPRU as conducted 5 large phase III clinical trials assessing different interventions for HIV prevention and enrolled over 7000 women. The trials were conducted at 7 community based research sites in the Durban and surrounding areas. Given the high HIV prevalence and incidence in our setting, every effort was made to integrate HIV prevention with treatment and care.

MDP 301 Trial Referral Process

  • Reasons for not accessing care (MDP 301 and SPARTAC)
  • Fear of disclosure of HIV status to family and/or friends
  • Stigma and discrimination: Many women knew people working at the clinics and were afraid of them discovering their HIV status.
  • Denial of their HIV status despite being positive for 3-4 years
  • Concerns on the side effects of ARVs: By participants and their families
  • Work commitments: Some women were too busy and could not afford missing work
  • Cost implications: High cost of travelling to and from the clinics
  • Distance: Some women reported that clinics are not easily accessible
  • Use of traditional medicines: Some women opted for traditional medicines while others were forced or influenced by their families.
  • Current Health Status: Many women report still feel healthy soon after seroconverting and don’t understand the implications of not enrolling into a programme.

Totalparticipants enrolled

N= 2391

  • The MDP 301 trial was implemented at 3 trial sites in Durban (Tongaat, Verulam and Isipingo) and enrolled 2391 women. All seroconvertors received a referral for further HIV related management to:
  • PEPFAR Care Clinic (operating at the Verulam HPRU clinic)
  • SPARTAC Treatment Trial
  • Local DoH service provider
    • Seroconvertors were contacted telephonically or via home visits to assess the uptake
    • of these referrals and any challenges encountered.
  • The SPARTAC trial is a randomised, controlled clinical trial that is currently conducted at 6 sites in Durban (Verulam, Isipingo, Umkomaas, Chatsworth, Botha’s Hill and Overport).
  • Participants who were acutely infected with HIV (HIV positive antibody test within 6-months of an HIV negative antibody test ) were randomised to 1 of 3 arms i.e. 48 weeks ARV treatment, 12 weeks ARV treatment or No therapy and followed for a period of 3.5 – 5 years. CD4 and Viral Loads were monitored during this period.
  • Between 2005 and 2007, 155 newly infected HIV positive women were recruited from then ongoing HPRU HIV prevention clinical trials. Of these, 87 enrolled into the SPARTAC trial.
  • Each participant was referred to the closest DoH clinic from the onset of the trial for further care, monitoring and enrolment into the National ARV programme.
  • To ensure that women did enrol into some care programme, staff tried to facilitate the process by providing transport, booking appointments and accompanying participants for visits.
  • Assessment on the uptake of referrals was done at each visit for participants during the 3.5- 5 year period.
  • Participant were requested to produce documents such as their clinic cards or feedback on their referral letters confirming enrolment into the national ARV programme.

No. seroconverted


Uptake of HIV Related Care Among Seroconvertors—Implications for VOICE or future HIV prevention trialsSharika Gappoo*, Sarita Naidoo, Yuki Sookrajh, Neetha Morar and Gita RamjeeHIV Prevention Research Unit, Medical Research Council, South Africa

Maintained contact

104 (63%)

Lost contact /LTFU



Access to HIV related care in resource poor settings can be attributed to the unavailability of efficient health services, financial constraints, stigma and other social barriers to care. Although South Africa has an established ARV Treatment programme, at the end of 2007 less than 31% of adults and children requiring ARV therapy were receiving it.

To help facilitate the referral process of trial participants to accessing care, the HPRU established a Memorandum of Understanding (MOU) with the Provincial Department of Health (DoH) and its associated service providers. This MOU was intended to help trial participants to access care related to HIV/AIDS, reproductive health and psychosocial care.The Referral process included:Counselling HIV positive participants at sites and then referring them for ongoing care to a public health service provider.Provision of a referral letter by the attending clinician or counsellor.Maintaining and updating a Referral log to include the details of the service providers closest to the trial sites.This sub-study examines the outcomes of the referrals provided to participants for HIV related care for 2 trials- -- HIV prevention trial: MDP 301- A randomised controlled trial testing Pro 2000 (05% and 2%) microbicide gel in 4 countries in Africa. -- 1 HIV treatment trial: SPARTAC- (Short Pulse Antiretroviral Therapy at HIV Seroconversion).

Refused to access care

16 (15%)

Accessed Referrals

77 (74%)

Enrolled in treatment Trial

11 (11%)

These 11 women joined the SPARTAC trial and are currently receiving care through this project

Many did not take up referrals due mainly to denial, stigma and other commitments (work, caring for children, etc.)

For most women it took several counselling sessions and a lot of encouragement before they eventually attended local clinics

SPARTAC Trial Referral Process


Access to care by participants: SPARTAC Trial

  • Despite having adequate referral systems and formalised partnerships with Health Care facilities, ensuring uptake of HIV related referral by participants who were HIV positive was a challenge.
  • Given the high HIV incidence in our setting, monitoring and evaluation of HIV related care by research participants is of utmost importance. Having and MOU may not suffice as there are multiple reasons for not accessing care.
  • The reasons identified as barriers to accessing care requires community wide intervention coupled with targeted counselling on a case by case basis.
  • For new trials such as VOICE (Vaginal and Oral Intervention to Control the Epidemic) HIV seroconvertors who may be exposed to ARV based intervention will require a more stringent mechanism to assess access to care which will include monitoring and evaluation of various factors that impede on participants accessing HIV related care.

Total enrolled in SPARTAC Trial

N = 87

Enrolled into

National Programme

67 (77%)

Not Enrolled in

National Programme

15 (17%)


5 (6%)

Never attended

Referral centre

5 (33%)

Previously enrolled in

National ARV Programme but discontinued

10 (67%)


  • To assess the access of HIV related care referrals by participants in the SPARTAC and MDP 301 Clinical Trials
  • To Identify common reasons for not accessing referrals for care at local DoH service providers

Some participants are still in denial of their HIV status or still feel healthy and don’t see the urgency to attend.

Of the 12 eligible for ARVs (CD4<200 copies/ul)-

11 are currently on long term treatment

Reasons for not attending follow up include: Time and cost constraints. Some do not have treatment supporter that can attend treatment classes with them

Acknowledgements: The participants of MDP and Spartac trials, The HPRU staff that contributed to the data, The Microbicides Development Programme (MDP) is a partnership of African, UK and Spanish academic/government institutions and commercial organisations.,

MDP is funded by the British Government Department for International Development (DIFD) and the UK Medical Research Council. MDP trial ISRCTN number is: ISRCTN64716212, The Clinical Trials Unit: SPARTAC Team; Welcome Trust: Subcontract Agreement Protocol No.:09