The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials: Experience from the HPTN 055 study

Gita Ramjee, Saidi Kapiga, Stephen M Weiss, Leigh Peterson, Corey Leburg, Cliff Kelly, Benoît Masse, Roshini Govinden, Nozizwe Dladla-Qwabe, Kodwa Mpepho, Yages Singh, Neetha Morar, Sten Vermund, Muzala Kapina Kanyanga, Sarah Chiduo, Longin Barongo, Noel Sam, George Seage, Wafaie Fawzi, Lori MillerTrong Ao, Tara Daley, Ireen Kiwelu, Basidi Bamba, Estomih Mduma, Msafiri Swai, Charles Mnbando, Margareth Maya, Lwice Macha, Stacie Kentop, Pete McDonnell, Geoff Minerbo, Karisse Román, Kayla Stratton, Lydia Soto-Torres, Roberta Black, Anne Coletti, Edward Livant, Estelle Piwowar-Manning, Sharon Hillier

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

OBJECTIVES: To evaluate the preparedness for phase 2/IIb/III microbicide trials at 4 clinical trial sites: Durban and Hlabisa (South Africa), Lusaka (Zambia), and Moshi (Tanzania). DESIGN: A prospective cohort study was undertaken to assess site suitability for microbicide efficacy studies. Study objectives included assessing sites' ability to recruit and retain high-risk women with the appropriate HIV incidence rates needed to conduct microbicide efficacy studies. METHODS: Nine hundred fifty-eight consenting women were enrolled and followed for up to 1 year. Demographic, behavioral, laboratory, and clinical data were collected to determine the incidence rates of HIV, sexually transmitted infections, and pregnancy. RESULTS: Accrual was completed in 6.3, 6.7, 7.1, and 8.3 months in Durban, Hlabisa, Moshi, and Lusaka, respectively. The highest month 12 participant retention rate was recorded in Durban (97%), followed by Hlabisa (94%), Moshi (86%), and Lusaka (93%). Mean overall age of enrolled participants was 28.6 years (ranging from 27.0 to 32.2 years) across sites. Despite condom counseling, rates of condom use were slightly lower at study end. Pregnancy incidence in the study as a whole was 20.2 per 100 women-years (wy). Overall HIV prevalence was 32.5%, and overall HIV incidence was 3.8 per 100 wy (95% confidence interval [CI]: 2.6 to 5.2). HIV incidence per site was 5.3 per 100 wy in Durban (95% CI: 2.7 to 9.2), 6.2 per 100 wy in Hlabisa (95% CI: 3.4 to 10.5); 2.6 per 100 wy in Lusaka (95% CI: 1.0 to 5.8), and 1.4 per 100 wy in Moshi (95% CI: 0.3 to 4.0). CONCLUSIONS: Preparatory studies provide accurate local estimates of HIV incidence, recruitment and retention rates, and behavioral characteristics of targeted populations for large-scale clinical trials. Determining these factors allows for better preparation for design, sample size, and appropriate population for future selection of trial sites. Because of the lower than expected HIV incidence observed at the Moshi site, only the South African and Zambian sites were selected for the phase 2/IIb trial.

Original languageEnglish
Pages (from-to)93-100
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes
Volume47
Issue number1
DOIs
StatePublished - Jan 1 2008

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HIV
Confidence Intervals
Incidence
Anti-Infective Agents
Condoms
Cohort Studies
Clinical Trials
Zambia
Pregnancy
Aptitude
Tanzania
Population Characteristics
Sexually Transmitted Diseases
South Africa
Sample Size
Counseling
Demography
Prospective Studies
Population

Keywords

  • Accrual
  • HIV/AIDS
  • Microbicide
  • Retention
  • Safety
  • Sexual behavior

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials : Experience from the HPTN 055 study. / Ramjee, Gita; Kapiga, Saidi; Weiss, Stephen M; Peterson, Leigh; Leburg, Corey; Kelly, Cliff; Masse, Benoît; Govinden, Roshini; Dladla-Qwabe, Nozizwe; Mpepho, Kodwa; Singh, Yages; Morar, Neetha; Vermund, Sten; Kanyanga, Muzala Kapina; Chiduo, Sarah; Barongo, Longin; Sam, Noel; Seage, George; Fawzi, Wafaie; Miller, Lori; Ao, Trong; Daley, Tara; Kiwelu, Ireen; Bamba, Basidi; Mduma, Estomih; Swai, Msafiri; Mnbando, Charles; Maya, Margareth; Macha, Lwice; Kentop, Stacie; McDonnell, Pete; Minerbo, Geoff; Román, Karisse; Stratton, Kayla; Soto-Torres, Lydia; Black, Roberta; Coletti, Anne; Livant, Edward; Piwowar-Manning, Estelle; Hillier, Sharon.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 47, No. 1, 01.01.2008, p. 93-100.

Research output: Contribution to journalArticle

Ramjee, G, Kapiga, S, Weiss, SM, Peterson, L, Leburg, C, Kelly, C, Masse, B, Govinden, R, Dladla-Qwabe, N, Mpepho, K, Singh, Y, Morar, N, Vermund, S, Kanyanga, MK, Chiduo, S, Barongo, L, Sam, N, Seage, G, Fawzi, W, Miller, L, Ao, T, Daley, T, Kiwelu, I, Bamba, B, Mduma, E, Swai, M, Mnbando, C, Maya, M, Macha, L, Kentop, S, McDonnell, P, Minerbo, G, Román, K, Stratton, K, Soto-Torres, L, Black, R, Coletti, A, Livant, E, Piwowar-Manning, E & Hillier, S 2008, 'The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials: Experience from the HPTN 055 study', Journal of Acquired Immune Deficiency Syndromes, vol. 47, no. 1, pp. 93-100. https://doi.org/10.1097/QAI.0b013e31815c71f7
Ramjee, Gita ; Kapiga, Saidi ; Weiss, Stephen M ; Peterson, Leigh ; Leburg, Corey ; Kelly, Cliff ; Masse, Benoît ; Govinden, Roshini ; Dladla-Qwabe, Nozizwe ; Mpepho, Kodwa ; Singh, Yages ; Morar, Neetha ; Vermund, Sten ; Kanyanga, Muzala Kapina ; Chiduo, Sarah ; Barongo, Longin ; Sam, Noel ; Seage, George ; Fawzi, Wafaie ; Miller, Lori ; Ao, Trong ; Daley, Tara ; Kiwelu, Ireen ; Bamba, Basidi ; Mduma, Estomih ; Swai, Msafiri ; Mnbando, Charles ; Maya, Margareth ; Macha, Lwice ; Kentop, Stacie ; McDonnell, Pete ; Minerbo, Geoff ; Román, Karisse ; Stratton, Kayla ; Soto-Torres, Lydia ; Black, Roberta ; Coletti, Anne ; Livant, Edward ; Piwowar-Manning, Estelle ; Hillier, Sharon. / The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials : Experience from the HPTN 055 study. In: Journal of Acquired Immune Deficiency Syndromes. 2008 ; Vol. 47, No. 1. pp. 93-100.
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title = "The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials: Experience from the HPTN 055 study",
abstract = "OBJECTIVES: To evaluate the preparedness for phase 2/IIb/III microbicide trials at 4 clinical trial sites: Durban and Hlabisa (South Africa), Lusaka (Zambia), and Moshi (Tanzania). DESIGN: A prospective cohort study was undertaken to assess site suitability for microbicide efficacy studies. Study objectives included assessing sites' ability to recruit and retain high-risk women with the appropriate HIV incidence rates needed to conduct microbicide efficacy studies. METHODS: Nine hundred fifty-eight consenting women were enrolled and followed for up to 1 year. Demographic, behavioral, laboratory, and clinical data were collected to determine the incidence rates of HIV, sexually transmitted infections, and pregnancy. RESULTS: Accrual was completed in 6.3, 6.7, 7.1, and 8.3 months in Durban, Hlabisa, Moshi, and Lusaka, respectively. The highest month 12 participant retention rate was recorded in Durban (97{\%}), followed by Hlabisa (94{\%}), Moshi (86{\%}), and Lusaka (93{\%}). Mean overall age of enrolled participants was 28.6 years (ranging from 27.0 to 32.2 years) across sites. Despite condom counseling, rates of condom use were slightly lower at study end. Pregnancy incidence in the study as a whole was 20.2 per 100 women-years (wy). Overall HIV prevalence was 32.5{\%}, and overall HIV incidence was 3.8 per 100 wy (95{\%} confidence interval [CI]: 2.6 to 5.2). HIV incidence per site was 5.3 per 100 wy in Durban (95{\%} CI: 2.7 to 9.2), 6.2 per 100 wy in Hlabisa (95{\%} CI: 3.4 to 10.5); 2.6 per 100 wy in Lusaka (95{\%} CI: 1.0 to 5.8), and 1.4 per 100 wy in Moshi (95{\%} CI: 0.3 to 4.0). CONCLUSIONS: Preparatory studies provide accurate local estimates of HIV incidence, recruitment and retention rates, and behavioral characteristics of targeted populations for large-scale clinical trials. Determining these factors allows for better preparation for design, sample size, and appropriate population for future selection of trial sites. Because of the lower than expected HIV incidence observed at the Moshi site, only the South African and Zambian sites were selected for the phase 2/IIb trial.",
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TY - JOUR

T1 - The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials

T2 - Experience from the HPTN 055 study

AU - Ramjee, Gita

AU - Kapiga, Saidi

AU - Weiss, Stephen M

AU - Peterson, Leigh

AU - Leburg, Corey

AU - Kelly, Cliff

AU - Masse, Benoît

AU - Govinden, Roshini

AU - Dladla-Qwabe, Nozizwe

AU - Mpepho, Kodwa

AU - Singh, Yages

AU - Morar, Neetha

AU - Vermund, Sten

AU - Kanyanga, Muzala Kapina

AU - Chiduo, Sarah

AU - Barongo, Longin

AU - Sam, Noel

AU - Seage, George

AU - Fawzi, Wafaie

AU - Miller, Lori

AU - Ao, Trong

AU - Daley, Tara

AU - Kiwelu, Ireen

AU - Bamba, Basidi

AU - Mduma, Estomih

AU - Swai, Msafiri

AU - Mnbando, Charles

AU - Maya, Margareth

AU - Macha, Lwice

AU - Kentop, Stacie

AU - McDonnell, Pete

AU - Minerbo, Geoff

AU - Román, Karisse

AU - Stratton, Kayla

AU - Soto-Torres, Lydia

AU - Black, Roberta

AU - Coletti, Anne

AU - Livant, Edward

AU - Piwowar-Manning, Estelle

AU - Hillier, Sharon

PY - 2008/1/1

Y1 - 2008/1/1

N2 - OBJECTIVES: To evaluate the preparedness for phase 2/IIb/III microbicide trials at 4 clinical trial sites: Durban and Hlabisa (South Africa), Lusaka (Zambia), and Moshi (Tanzania). DESIGN: A prospective cohort study was undertaken to assess site suitability for microbicide efficacy studies. Study objectives included assessing sites' ability to recruit and retain high-risk women with the appropriate HIV incidence rates needed to conduct microbicide efficacy studies. METHODS: Nine hundred fifty-eight consenting women were enrolled and followed for up to 1 year. Demographic, behavioral, laboratory, and clinical data were collected to determine the incidence rates of HIV, sexually transmitted infections, and pregnancy. RESULTS: Accrual was completed in 6.3, 6.7, 7.1, and 8.3 months in Durban, Hlabisa, Moshi, and Lusaka, respectively. The highest month 12 participant retention rate was recorded in Durban (97%), followed by Hlabisa (94%), Moshi (86%), and Lusaka (93%). Mean overall age of enrolled participants was 28.6 years (ranging from 27.0 to 32.2 years) across sites. Despite condom counseling, rates of condom use were slightly lower at study end. Pregnancy incidence in the study as a whole was 20.2 per 100 women-years (wy). Overall HIV prevalence was 32.5%, and overall HIV incidence was 3.8 per 100 wy (95% confidence interval [CI]: 2.6 to 5.2). HIV incidence per site was 5.3 per 100 wy in Durban (95% CI: 2.7 to 9.2), 6.2 per 100 wy in Hlabisa (95% CI: 3.4 to 10.5); 2.6 per 100 wy in Lusaka (95% CI: 1.0 to 5.8), and 1.4 per 100 wy in Moshi (95% CI: 0.3 to 4.0). CONCLUSIONS: Preparatory studies provide accurate local estimates of HIV incidence, recruitment and retention rates, and behavioral characteristics of targeted populations for large-scale clinical trials. Determining these factors allows for better preparation for design, sample size, and appropriate population for future selection of trial sites. Because of the lower than expected HIV incidence observed at the Moshi site, only the South African and Zambian sites were selected for the phase 2/IIb trial.

AB - OBJECTIVES: To evaluate the preparedness for phase 2/IIb/III microbicide trials at 4 clinical trial sites: Durban and Hlabisa (South Africa), Lusaka (Zambia), and Moshi (Tanzania). DESIGN: A prospective cohort study was undertaken to assess site suitability for microbicide efficacy studies. Study objectives included assessing sites' ability to recruit and retain high-risk women with the appropriate HIV incidence rates needed to conduct microbicide efficacy studies. METHODS: Nine hundred fifty-eight consenting women were enrolled and followed for up to 1 year. Demographic, behavioral, laboratory, and clinical data were collected to determine the incidence rates of HIV, sexually transmitted infections, and pregnancy. RESULTS: Accrual was completed in 6.3, 6.7, 7.1, and 8.3 months in Durban, Hlabisa, Moshi, and Lusaka, respectively. The highest month 12 participant retention rate was recorded in Durban (97%), followed by Hlabisa (94%), Moshi (86%), and Lusaka (93%). Mean overall age of enrolled participants was 28.6 years (ranging from 27.0 to 32.2 years) across sites. Despite condom counseling, rates of condom use were slightly lower at study end. Pregnancy incidence in the study as a whole was 20.2 per 100 women-years (wy). Overall HIV prevalence was 32.5%, and overall HIV incidence was 3.8 per 100 wy (95% confidence interval [CI]: 2.6 to 5.2). HIV incidence per site was 5.3 per 100 wy in Durban (95% CI: 2.7 to 9.2), 6.2 per 100 wy in Hlabisa (95% CI: 3.4 to 10.5); 2.6 per 100 wy in Lusaka (95% CI: 1.0 to 5.8), and 1.4 per 100 wy in Moshi (95% CI: 0.3 to 4.0). CONCLUSIONS: Preparatory studies provide accurate local estimates of HIV incidence, recruitment and retention rates, and behavioral characteristics of targeted populations for large-scale clinical trials. Determining these factors allows for better preparation for design, sample size, and appropriate population for future selection of trial sites. Because of the lower than expected HIV incidence observed at the Moshi site, only the South African and Zambian sites were selected for the phase 2/IIb trial.

KW - Accrual

KW - HIV/AIDS

KW - Microbicide

KW - Retention

KW - Safety

KW - Sexual behavior

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