Oral Abstract Session 01 - Global HIV Vaccine Enterprise

Topic 4: Clinical Vaccine Trials and Trial Site Challenges
P04.09
Sexual Behavior Among Volunteers Enrolled in a
Phase I HIV Vaccine Trial:
Experience of Projet San Francisco in Kigali, Rwanda
J. Mukamuyango 1 , E. Karita 1 , R. Bayingana 1 , J. Nyombayire 1 ,
R. Ingabire 1 , S. Allen 2 , A. Tichacek 2 , P. Fast 3 , M. Price 3 , C. Schmidt 3
1 Projet San Francisco, Kigali, Rwanda; 2 Emory University,
Atlanta, GA, USA; 3 International AIDS Vaccine Initiative, New
York, NY, USA
Background: Phase 1 HIV vaccine trials are conducted among
HIV-uninfected, healthy volunteers at low risk for HIV. Study
volunteers are counseled to maintain low risk behavior for HIV
acquisition. The objective of this study was to assess sexual
behavior of volunteers in a Phase 1 vaccine trial, conducted in
Kigali, Rwanda.
Methods: Concordant HIV-negative couples who were counseled
and tested together were considered as low risk group for HIV
acquisition and were invited to participate in Phase 1 HIV vaccine
trial to evaluate safety and immunogenicity of a multiclade HIV-
1 DNA plasmid vaccine followed by a recombinant, multiclade
HIV-1 adenoviral vector vaccine (IAVI V001). HIV risk reduction
counseling, assessment of sexual behavior and screening for
sexually transmitted infections (STI) were conducted quarterly.
After completion of the vaccine trial, participants and their
partners were invited to participate in a long-term 5-year followup
study from their last vaccination for further assessment of
sexual behavior and continuous risk reduction counseling.
Results: Between November 2005 and May 2006, 57 volunteers
(36 men and 21 women) were enrolled in the clinical trial. All
volunteers completed their trial visits. During the first twelve
months following the first vaccination, none of the study
participants reported sex with other partners nor was treated
for STI. After unblinding, 55 volunteers agreed to continue in
long-term follow up study. Through January 2012 6 men and 2
women reported having sex at least once with other partners;
two were treated for STI, and one subsequently acquired HIV.
(HIV incidence rate: 0.3/100 person-years).
Conclusion: This trial and subsequent follow-up study confirm
our previous findings that concordant HIV-negative couples are at
low risk of HIV infection and suitable for enrolling in Phase 1 HIV
prevention trials. Ongoing HIV risk reduction counseling should be
provided during the trial as well as after the trail, if possible.
P04.10
AIDS Vaccine 2012
Posters
Developing Standards of Care for HIV Prevention
Research in Developing Countries – A Case Study of
Ten Research Centers in Eastern and Southern Africa
B.P. Ngongo 1 , F. Priddy 1 , H. Park 1 , B. Bender 1 , P. Fast 1 , O. Anzala 2 ,
G. Mutua 2 , E. Ruzagira 3 , A. Kamali 4 , E. Karita 5 , P. Mugo 6 ,
E. Chomba 7 , L. Bekker 8 , S. Roux 8 , A. Nanvubya 9 , T. Mebrahtu 9
1 International AIDS Vaccine Initiative, Nairobi, Kenya; 2 Kenya
AIDS Vaccine Initiative, Nairobi, Kenya; 3 Medical Research
Council – UVRI, Entebbe, Uganda; 4 MRC-UVRI, Entebbe,
Uganda; 5 Projet San Francisco, Kigali, Rwanda; 6 KEMRI-
CGMRC, Kilifi, Kenya; 7 Zambia Emory HIV Research Program,
Lusaka, Zambia; 8 Desmond Tutu HIV Foundation, Cape
Town, South Africa; 9 Uganda Virus Research Institute – IAVI,
Entebbe, Uganda
Background: Standards of care in general vary across countries
and communities and thus may affect decisions about standards
of care provided by research centers in HIV prevention research.
To serve as a basis for clarifying and improving standards, a
systematic survey of practices at 10 experienced research centers
affiliated with the International AIDS Vaccine Initiative in Eastern
and Southern Africa was conducted between 2008 and 2010.
Methods: A survey tool was developed to collect qualitative
and quantitative data on types of services provided, recipients
of services, referral systems and barriers to referral uptake.
Focus group discussion and semi-structured interviews were
conducted with key research centre staff. Qualitative data were
coded and enumerated where appropriate. Quantitative data
were categorized and tabulated using STATA.
Results: All research centres consistently provided HIV prevention
and care services but had varied practices on family planning
options, and general medical care to research volunteers, screen
out volunteers, partners of volunteers, and former volunteers.
Services that were less consistently provided included
provision of female condoms and anti-retroviral post-exposureprophylaxis
to volunteers in case of rape. All research centres
either had referral points for treatment and care for volunteers
who become infected with HIV or provided the services on-site.
Limited referral points were available for psychosocial services
and adult male circumcision. The greatest challenges for referral
uptake included transportation and health care costs, poor
quality and inconsistency of services at some referral points.
While all research centres covered the cost of health services for
study-related adverse events, policies varied on covering the cost
of other health services.
Conclusion: These findings informed the development of
standards of care across the 10 research centers and for IAVIsponsored
research. In developing such standards, balance
should be made between scientific priorities, considerations
of fairness, contextual realities, community expectations, and
cost-effectiveness of conducting clinical trials
153
POSTERS