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1. Prospective longitudinal study of men who have sex with men and transgender women to determine HIV incidence in two provinces in Thailand.

Author

Namwat, Chawetsan, Leela-Apiradee, Warong, Tiawilai, Thawat, Dear, Nicole, Wansom, Tanyaporn, Kitsiripornchai, Suchai, Premsri, Nakorn, Akapirat, Siriwat, Crowell, Trevor A., Francisco, Leilani, Li, Qun, Robb, Merlin L., Smith, Kirsten S., Heger, Elizabeth A., Fukuda, Mark M., O'Connell, Robert J., Rerks-Ngarm, Supachai, and Vasan, Sandhya

Subjects
PROPORTIONAL hazards models, ANAL sex, HIV seroconversion, TRANSGENDER people, HIV infection transmission
Abstract

Background: In Thailand, HIV transmission is well characterized in large urban centers such as Bangkok and Chiang Mai but less so outside of these areas. The main purpose of this study was to assess HIV incidence and associated risk factors in Nakhon Ratchasima and Ratchaburi. Methods: Participants assigned male sex at birth were enrolled in this prospective observational cohort study between November 2017 and July 2018. HIV and syphilis testing and sociobehavioral questionnaires were administered over 18 months. HIV incidence rates and 95% confidence intervals (CIs) were estimated using a Poisson distribution. Cox proportional hazards models were used to estimate unadjusted and adjusted hazard ratios (aHRs) and 95% CIs for associations between potential risk factors and HIV seroconversion. Results: A total of 1003 participants were enrolled. Overall HIV incidence was 1.56 per 100 person-years (95% CI:1.02–2.44) and similar at both sites. In the fully adjusted model, sex with a sex worker in the past six months was associated with reduced risk of seroconversion (aHR:0.10, 95% CI:0.01–0.77). In the reduced adjusted model, receptive anal sex (aHR:3.40, 95% CI:1.32–8.74) and STI diagnosis in the past six months (aHR:3.58, 95% CI:1.19–10.76) were associated with seroconversion, while sex with a sex worker in the past six months was associated with reduced risk of seroconversion (aHR:0.11, 95% CI:0.02–0.67). Additionally, 56% reported interest in taking PrEP and 82% reported willingness to participate in a hypothetical future vaccine trial. Conclusions: Recent receptive anal sex practices were associated with HIV acquisition in these populations, highlighting the continued need for interventions encouraging safer anal sex practices to reduce HIV incidence. [ABSTRACT FROM AUTHOR]

Published
2024
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2. HIV prevalence and awareness among adults presenting for enrolment into a study of people at risk for HIV in Kisumu County, Western Kenya.

Author

Sing'oei, Valentine, Nwoga, Chiaka, Yates, Adam, Owuoth, John, Otieno, June, Broach, Erica, Li, Qun, Hassen, Zebiba, Imbach, Michelle, Milazzo, Mark, Mebrahtu, Tsedal, Robb, Merlin L., Ake, Julie A., Polyak, Christina S., and Crowell, Trevor A.

Subjects
HIV, DIAGNOSIS of HIV infections, HIV infection transmission, AT-risk people, HIV prevention, POISSON regression
Abstract

Introduction: Despite declines in new HIV diagnoses both globally and in Kenya, parts of Western Kenya still report high HIV prevalence and incidence. We evaluated HIV prevalence to inform the development of policies for strategic and targeted HIV prevention interventions. Methods: Adult participants aged 18–35 years were recruited in Kisumu County and screened for HIV for a prospective HIV incidence cohort. Questionnaires assessed HIV-associated risk behaviors. Participants who tested positive for HIV were disaggregated into groups based on prior knowledge of their HIV status: previously-diagnosed and newly-diagnosed. In separate analyses by prior knowledge, robust Poisson regression was used to estimate prevalence ratios (PRs) and 95% confidence intervals (CIs) for factors potentially associated with a positive HIV test in each group, as compared to participants without HIV. Results: Of 1059 participants tested for HIV, 196 (18.5%) had a positive HIV test. Among PLWH, 78 (39.8%) were newly diagnosed with HIV at screening. After adjusting for other variables, previously-diagnosed HIV was more common among females than males (PR 2.70, 95%CI 1.69–4.28), but there was no observed sex difference in newly-diagnosed HIV prevalence (PR 1.05, 95%CI 0.65–1.69). Previously-diagnosed HIV was also more common among people reporting consistent use of condoms with primary sexual partners as compared to inconsistent condom use (PR 3.19, 95%CI 2.09–4.86), but newly-diagnosed HIV was not associated with such a difference between consistent and inconsistent condom use (PR 0.73, 95%CI 0.25–2.10). Conclusion: Prevalence of newly-diagnosed HIV was high, at approximately 8% of participants, and not statistically different between genders, highlighting the need for improved HIV case finding regardless of sex. The higher prevalence of previously-diagnosed HIV in female participants may reflect higher rates of HIV testing through more encounters with the healthcare system. Higher prevalence of consistent condom use amongst those previously-diagnosed suggests behavioral change to reduce HIV transmission, a potential benefit of policies to facilitate earlier HIV diagnosis. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4

Author

Sing’oei, Valentine, primary, Ochola, Jew, additional, Owuoth, John, additional, Otieno, June, additional, Rono, Eric, additional, Andagalu, Ben, additional, Otieno, Lucas, additional, Nwoga, Chiaka, additional, Copeland, Nathanial K., additional, Lawlor, John, additional, Yates, Adam, additional, Imbach, Michelle, additional, Crowell, Trevor A., additional, Eller, Leigh Anne, additional, Kamau, Edwin, additional, Modjarrad, Kayvon, additional, Cowden, Jessica, additional, Ake, Julie, additional, Robb, Merlin L., additional, and Polyak, Christina S., additional

Published
2021
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4. Determining hematological, biochemical and immunological reference values in healthy adults with high-risk for HIV acquisition in Mozambique

Author

Cumbane, Victória, primary, Imbach, Michelle, additional, Chissumba, Raquel Matavele, additional, Macicame, Ivalda, additional, Eller, Leigh Anne, additional, Lawlor, John, additional, Milazzo, Mark, additional, Li, Qun, additional, Crowell, Trevor, additional, Mutombene, Mirna, additional, Guiliche, Onélia, additional, Viegas, Edna, additional, Nwoga, Chiaka, additional, Yates, Adam, additional, Michael, Nelson, additional, Robb, Merlin, additional, Polyak, Christina S., additional, Jani, Ilesh V., additional, and Bhatt, Nilesh, additional

Published
2020
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5. Young at risk-people in Maputo City, Mozambique, present a high willingness to participate in HIV trials: Results from an HIV vaccine preparedness cohort study.

Author

Capitine, Igor P. U., Macicame, Ivalda B., Uanela, Artur M., Bhatt, Nilesh B., Yates, Adam, Milazzo, Mark, Nwoga, Chiaka, Crowell, Trevor A., Michael, Nelson L., Robb, Merlin L., Jani, Ilesh V., Kroidl, Arne, Polyak, Christina S., and De Schacht, Caroline

Subjects
AIDS vaccines, VACCINE trials, HUMAN sexuality, GENERALIZED estimating equations, LOGISTIC regression analysis, HIV infections, HIV
Abstract

Introduction: Vaccine efficacy testing requires engagement of willing volunteers with high disease incidence. We evaluated factors associated with willingness to participate in potential future HIV vaccine trials in Maputo, Mozambique. Methods: Adults aged 18–35 years without HIV and who reported at least two sexual partners in the 3 months prior to screening were enrolled into a 24-month observational study. They were asked at screening and exit if they would be willing to participate in a theoretical HIV vaccine study. Bivariate and multivariate logistic regression analyses were done between willingness to participate, demographic, sexual behavior, and motivational factors for screening visit data. Logistic regression with generalized estimating equations (GEE) was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors potentially associated with willingness to participate for data from both visits. Results: A total of 577 participants without HIV were eligible, including 275 (48%) women. The mean age was 22.2 (SD ± 3.9) years. At screening 529 (92%) expressed willingness to participate and the proportion remained stable at 378 (88%) of the 430 participants retained through the exit visit (p = 0.209). Helping the country (n = 556) and fear of needles (n = 26) were the top motive and barrier for willingness to participate, respectively. Results from the GEE binary logistic regression (screening visit and exit visit) showed that wanting to learn how to avoid risk behaviors (aOR 3.33, 95% CI: 1.61–6.86) and feeling protected against HIV infection (aOR 2.24, 95% CI: 1.07–4.7) were associated with willingness to participate in HIV vaccine studies. Conclusion: The majority of our study population in Mozambique expressed willingness to participate in a theoretical HIV vaccine trial. Participation in a HIV vaccine trial was seen as a way to contribute to the fight against HIV but was associated with some unrealistic expectations such as protection against HIV. This reinforces the need for continuous mobilization and awareness of potential participants to HIV vaccine trial. [ABSTRACT FROM AUTHOR]

Published
2021
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6. Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans

Author

Zhao, Lue Ping, primary, Fiore-Gartland, Andrew, additional, Carpp, Lindsay N., additional, Cohen, Kristen W., additional, Rouphael, Nadine, additional, Fleurs, Llewellyn, additional, Dintwe, One, additional, Zhao, Michael, additional, Moodie, Zoe, additional, Fong, Youyi, additional, Garrett, Nigel, additional, Huang, Ying, additional, Innes, Craig, additional, Janes, Holly E., additional, Lazarus, Erica, additional, Michael, Nelson L., additional, Nitayaphan, Sorachai, additional, Pitisuttithum, Punnee, additional, Rerks-Ngarm, Supachai, additional, Robb, Merlin L., additional, De Rosa, Stephen C., additional, Corey, Lawrence, additional, Gray, Glenda E., additional, Seaton, Kelly E., additional, Yates, Nicole L., additional, McElrath, M. Juliana, additional, Frahm, Nicole, additional, Tomaras, Georgia D., additional, and Gilbert, Peter B., additional

Published
2020
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7. HIV prevalence and risk behavior among male and female adults screened for enrolment into a vaccine preparedness study in Maputo, Mozambique

Author

Macicame, Ivalda, primary, Bhatt, Nilesh, additional, Matavele Chissumba, Raquel, additional, Eller, Leigh Anne, additional, Viegas, Edna, additional, Araújo, Khelvon, additional, Nwoga, Chiaka, additional, Li, Qun, additional, Milazzo, Mark, additional, Hills, Nancy K., additional, Lindan, Christina, additional, Michael, Nelson L., additional, Robb, Merlin L., additional, Jani, Ilesh, additional, and Polyak, Christina S., additional

Published
2019
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8. HIV-1 genetic diversity and demographic characteristics in Bulgaria

Author

Billings, Erik, primary, Heipertz, Richard A., additional, Varleva, Tonka, additional, Sanders-Buell, Eric, additional, O'Sullivan, Anne Marie, additional, Bose, Meera, additional, Howell, Shana, additional, Kijak, Gustavo H., additional, Taskov, Hristo, additional, Elenkov, Ivailo, additional, Nenova, Marina, additional, Popivanova, Nedialka, additional, Valenzuela, Aimee Bolen, additional, Myles, Otha, additional, Bautista, Christian T., additional, Robb, Merlin L., additional, Michael, Nelson L., additional, Kim, Jerome H., additional, Scott, Paul T., additional, Tovanabutra, Sodsai, additional, and Ake, Julie A., additional

Published
2019
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9. Clinical laboratory reference values in adults in Kisumu County, Western Kenya; hematology, chemistry and CD4.

Author

Sing'oei, Valentine, Ochola, Jew, Owuoth, John, Otieno, June, Rono, Eric, Andagalu, Ben, Otieno, Lucas, Nwoga, Chiaka, Copeland, Nathanial K., Lawlor, John, Yates, Adam, Imbach, Michelle, Crowell, Trevor A., Eller, Leigh Anne, Kamau, Edwin, Modjarrad, Kayvon, Cowden, Jessica, Ake, Julie, Robb, Merlin L., and Polyak, Christina S.

Subjects
REFERENCE values, CD4 lymphocyte count, HEMATOLOGY, GENETICS, GENDER
Abstract

Background: Clinical laboratory reference intervals (RIs) are essential for diagnosing and managing patients in routine clinical care as well as establishing eligibility criteria and defining adverse events in clinical trials, but may vary by age, gender, genetics, nutrition and geographic location. It is, therefore, critical to establish region-specific reference values in order to inform clinical decision-making. Methods: We analyzed data from a prospective observational HIV incidence cohort study in Kombewa, Kenya. Study participants were healthy males and females, aged 18–35 years, without HIV. Median and 95% reference values (2.5th percentile to 97.5th percentile) were calculated for laboratory parameters including hematology, chemistry studies, and CD4 T cell count. Standard Deviation Ratios (SDR) and Bias Ratios (BR) are presented as measures of effect magnitude. Findings were compared with those from the United States and other Kenyan studies. Results: A total of 299 participants were analyzed with a median age of 24 years (interquartile range: 21–28). Ratio of males to females was 0.9:1. Hemoglobin range (2.5th—97.5th percentiles) was 12.0–17.9 g/dL and 9.5–15.3 g/dL in men and women respectively. In the cohort, MCV range was 59-95fL, WBC 3.7–9.2×103/μL, and platelet 154–401×103/μL. Chemistry values were higher in males; the creatinine RI was 59–103 μmol/L in males vs. 46–76 μmol/L in females (BRUL>.3); and the alanine transferase range was 8.8–45.3 U/L in males vs. 7.5–36.8 U/L in females (SDR>.3). The overall CD4 T cell count RI was 491–1381 cells/μL. Some parameters including hemoglobin, neutrophil, creatinine and ALT varied with that from prior studies in Kenya and the US. Conclusion: This study not only provides clinical reference intervals for a population in Kisumu County but also highlights the variations in comparable settings, accentuating the requirement for region-specific reference values to improve patient care, scientific validity, and quality of clinical trials in Africa. [ABSTRACT FROM AUTHOR]

Published
2021
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10. HIV virologic failure and its predictors among HIV-infected adults on antiretroviral therapy in the African Cohort Study

Author

Kiweewa, Francis, primary, Esber, Allahna, additional, Musingye, Ezra, additional, Reed, Domonique, additional, Crowell, Trevor A., additional, Cham, Fatim, additional, Semwogerere, Michael, additional, Namagembe, Rosemary, additional, Nambuya, Alice, additional, Kafeero, Cate, additional, Tindikahwa, Allan, additional, Eller, Leigh Anne, additional, Millard, Monica, additional, Gelderblom, Huub C., additional, Keshinro, Babajide, additional, Adamu, Yakubu, additional, Maswai, Jonah, additional, Owuoth, John, additional, Sing’oei, Valentine Chepkorir, additional, Maganga, Lucas, additional, Bahemana, Emmanuel, additional, Khamadi, Samoel, additional, Robb, Merlin L., additional, Ake, Julie A., additional, Polyak, Christina S., additional, and Kibuuka, Hannah, additional

Published
2019
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11. Oral sex practices among men who have sex with men and transgender women at risk for and living with HIV in Nigeria.

Author

Robbins, Sarah J., Dauda, Wuese, Kokogho, Afoke, Ndembi, Nicaise, Mitchell, Andrew, Adebajo, Sylvia, Gaydos, Charlotte A., Peel, Sheila, Ramadhani, Habib O., Robb, Merlin L., Baral, Stefan D., Ake, Julie A., Charurat, Man E., Crowell, Trevor A., and Nowak, Rebecca G.

Subjects
ORAL sex, HIV-positive women, ANAL sex, SEXUALLY transmitted diseases, NEISSERIA gonorrhoeae
Abstract

Background: Men who have sex with men (MSM) and transgender women (TGW) are at risk for sexually transmitted infections (STIs), including those of the oropharynx. We estimated the prevalence and factors associated with oral sex practices and characterized oropharyngeal STIs among a cohort of MSM and TGW in Nigeria. Methods: From 2013 to 2018, TRUST/RV368 recruited MSM and TGW into HIV/STI diagnosis and treatment at community-based clinics in Nigeria. Participants who completed HIV testing and oral sex questions at enrollment were selected. Cross-sectional analyses with bivariate and multivariable logistic regression models estimated odds ratios (ORs) and 95% confidence intervals (CIs). Oropharyngeal swab testing for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) began in 2014 and for those with diagnostic results at enrollment, the unadjusted association of oral sex practices with oropharyngeal STIs was conducted. Results: A total of 1342 participants had a median age of 25 years (interquartile range: 22–29), 58% were living with HIV, and 69% reported oral sex practices. Factors associated with increased odds of engaging in oral sex included living with HIV (adjusted [a]OR: 1.4, 95% CI: 1.1–1.8), self-identifying as a woman (aOR:1.8, 95% CI: 1.1–2.8), mobile phone ownership (aOR:2.3, 95% CI: 1.3–3.9), receptive anal sex (aOR:1.7, 95% CI:1.3–2.3) and multiple male sexual partners (2 to 4 vs. ≤1, aOR:1.5, 95% CI: 1.0–2.2; 5+ vs ≤1, aOR:2.9, 95% CI:1.9–4.3). Oropharyngeal STI prevalence was 7% (52/752) and higher among those who engaged in oral sex compared to those who did not (unadjusted OR: 2.5, 95% CI:1.2–5.3). Conclusions: Oral sex was common and associated with an increased odds of oropharyngeal STIs among MSM and TGW from Nigeria. In the absence of screening and treatment guidelines, condoms continue to be the mainstay for oral STI prevention. A pre-exposure prophylaxis for bacterial STIs would complement current prevention strategies to curb transmission. [ABSTRACT FROM AUTHOR]

Published
2020
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12. Seizing opportunities for intervention: Changing HIV-related knowledge among men who have sex with men and transgender women attending trusted community centers in Nigeria.

Author

Jones, Milissa U., Ramadhani, Habib O., Adebajo, Sylvia, Gaydos, Charlotte A., Kokogho, Afoke, Baral, Stefan D., Nowak, Rebecca G., Ake, Julie A., Liu, Hongjie, Charurat, Manhattan E., Robb, Merlin L., and Crowell, Trevor A.

Subjects
COMMUNITY centers, HIV seroconversion, HUMAN sexuality, POISSON regression, HIV, PUBLIC health
Abstract

Background: Knowledge of HIV risk factors and reduction strategies is essential for prevention in key populations such as men who have sex with men (MSM) and transgender women (TGW). We evaluated factors associated with HIV-related knowledge among MSM and TGW and the impact of engagement in care at trusted community health centers in Nigeria. Methods: The TRUST/RV368 cohort recruited MSM and TGW in Lagos and Abuja, Nigeria via respondent driven sampling. During study visits every three months, participants underwent structured interviews to collect behavioral data, received HIV education, and were provided free condoms and condom compatible lubricants. Five HIV-related knowledge questions were asked at enrollment and repeated after 9 and 15 months. The mean number of correct responses was calculated for each visit with 95% confidence intervals (CIs). Multivariable Poisson regression was used to calculate adjusted risk ratios and CIs for factors associated with answering more knowledge questions correctly. Results: From March 2013 to April 2018, 2122 persons assigned male sex at birth were enrolled, including 234 TGW (11.2%). The mean number of correct responses at enrollment was 2.36 (95% CI: 2.31–2.41) and increased to 2.95 (95% CI: 2.86–3.04) and 3.06 (95% CI: 2.97–3.16) after 9 and 15 months in the study, respectively. Among 534 participants who completed all three HIV-related knowledge assessments, mean number of correct responses rose from 2.70 (95% CI: 2.60–2.80) to 3.02 (95% CI: 2.93–3.13) and then 3.06 (95% CI: 2.96–3.16). Factors associated with increased overall HIV-related knowledge included longer duration of study participation, HIV seropositivity, higher education level, and more frequent internet use. Conclusions: There was suboptimal HIV-related knowledge among Nigerian MSM and TGW at that improved modestly with engagement in care. These data demonstrate unmet HIV education needs among Nigerian MSM and TGW and provide insights into modalities that could be used to address these needs. [ABSTRACT FROM AUTHOR]

Published
2020
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13. Sieve analysis of breakthrough HIV-1 sequences in HVTN 505 identifies vaccine pressure targeting the CD4 binding site of Env-gp120

Author

deCamp, Allan C., primary, Rolland, Morgane, additional, Edlefsen, Paul T., additional, Sanders-Buell, Eric, additional, Hall, Breana, additional, Magaret, Craig A., additional, Fiore-Gartland, Andrew J., additional, Juraska, Michal, additional, Carpp, Lindsay N., additional, Karuna, Shelly T., additional, Bose, Meera, additional, LePore, Steven, additional, Miller, Shana, additional, O'Sullivan, Annemarie, additional, Poltavee, Kultida, additional, Bai, Hongjun, additional, Dommaraju, Kalpana, additional, Zhao, Hong, additional, Wong, Kim, additional, Chen, Lennie, additional, Ahmed, Hasan, additional, Goodman, Derrick, additional, Tay, Matthew Z., additional, Gottardo, Raphael, additional, Koup, Richard A., additional, Bailer, Robert, additional, Mascola, John R., additional, Graham, Barney S., additional, Roederer, Mario, additional, O’Connell, Robert J., additional, Michael, Nelson L., additional, Robb, Merlin L., additional, Adams, Elizabeth, additional, D’Souza, Patricia, additional, Kublin, James, additional, Corey, Lawrence, additional, Geraghty, Daniel E., additional, Frahm, Nicole, additional, Tomaras, Georgia D., additional, McElrath, M. Juliana, additional, Frenkel, Lisa, additional, Styrchak, Sheila, additional, Tovanabutra, Sodsai, additional, Sobieszczyk, Magdalena E., additional, Hammer, Scott M., additional, Kim, Jerome H., additional, Mullins, James I., additional, and Gilbert, Peter B., additional

Published
2017
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14. V1V2-specific complement activating serum IgG as a correlate of reduced HIV-1 infection risk in RV144

Author

Perez, Lautaro G., primary, Martinez, David R., additional, deCamp, Allan C., additional, Pinter, Abraham, additional, Berman, Phillip W., additional, Francis, Donald, additional, Sinangil, Faruk, additional, Lee, Carter, additional, Greene, Kelli, additional, Gao, Hongmei, additional, Nitayaphan, Sorachai, additional, Rerks-Ngarm, Supachai, additional, Kaewkungwal, Jaranit, additional, Pitisuttithum, Punnee, additional, Tartaglia, James, additional, O’Connell, Robert J., additional, Robb, Merlin L., additional, Michael, Nelson L., additional, Kim, Jerome H., additional, Gilbert, Peter, additional, and Montefiori, David C., additional

Published
2017
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15. Antibody to HSV gD peptide induced by vaccination does not protect against HSV-2 infection in HSV-2 seronegative women

Author

Gilbert, Peter B., primary, Excler, Jean-Louis, additional, Tomaras, Georgia D., additional, Carpp, Lindsay N., additional, Haynes, Barton F., additional, Liao, Hua-Xin, additional, Montefiori, David C., additional, Rerks-Ngarm, Supachai, additional, Pitisuttithum, Punnee, additional, Nitayaphan, Sorachai, additional, Kaewkungwal, Jaranit, additional, Kijak, Gustavo H., additional, Tovanabutra, Sodsai, additional, Francis, Donald P., additional, Lee, Carter, additional, Sinangil, Faruk, additional, Berman, Phillip W., additional, Premsri, Nakorn, additional, Kunasol, Prayura, additional, O’Connell, Robert J., additional, Michael, Nelson L., additional, Robb, Merlin L., additional, Morrow, Rhoda, additional, Corey, Lawrence, additional, and Kim, Jerome H., additional

Published
2017
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16. An Evaluation of Selected Populations for HIV-1 Vaccine Cohort Development in Nigeria

Author

Njoku, Ogbonnaya S., primary, Manak, Mark M., additional, O’Connell, Robert J., additional, Shutt, Ashley L. W., additional, Malia, Jennifer A., additional, Heipertz, Richard A., additional, Tovanabutra, Sodsai, additional, Milazzo, Mark J., additional, Akintunde, Gideon Akindiran, additional, Alabi, Abraham S., additional, Suleiman, Aminu, additional, Ogundeji, Amos A., additional, Kene, Terfa S., additional, Nelson, Robbie, additional, Ayemoba, Ojor R., additional, Singer, Darrell E., additional, Robb, Merlin L., additional, Peel, Sheila A., additional, and Michael, Nelson L., additional

Published
2016
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17. Boosting with Subtype C CN54rgp140 Protein Adjuvanted with Glucopyranosyl Lipid Adjuvant after Priming with HIV-DNA and HIV-MVA Is Safe and Enhances Immune Responses: A Phase I Trial

Author

Joachim, Agricola, primary, Bauer, Asli, additional, Joseph, Sarah, additional, Geldmacher, Christof, additional, Munseri, Patricia J., additional, Aboud, Said, additional, Missanga, Marco, additional, Mann, Philipp, additional, Wahren, Britta, additional, Ferrari, Guido, additional, Polonis, Victoria R., additional, Robb, Merlin L., additional, Weber, Jonathan, additional, Tatoud, Roger, additional, Maboko, Leonard, additional, Hoelscher, Michael, additional, Lyamuya, Eligius F., additional, Biberfeld, Gunnel, additional, Sandström, Eric, additional, Kroidl, Arne, additional, Bakari, Muhammad, additional, Nilsson, Charlotta, additional, and McCormack, Sheena, additional

Published
2016
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18. Optimizing the immunogenicity of HIV prime-boost DNA-MVA-rgp140/GLA vaccines in a phase II randomized factorial trial design.

Author

Viegas, Edna O., Kroidl, Arne, Munseri, Patricia J., Missanga, Marco, Nilsson, Charlotta, Tembe, Nelson, Bauer, Asli, Joachim, Agricola, Joseph, Sarah, Mann, Philipp, Geldmacher, Christof, Fleck, Sue, Stöhr, Wolfgang, Scarlatti, Gabriella, Aboud, Said, Bakari, Muhammad, Maboko, Leonard, Hoelscher, Michael, Wahren, Britta, and Robb, Merlin L.

Subjects
INTRADERMAL injections, HIV virus evolution, IMMUNOGENETICS, ELECTROPORATION, BIOELECTROCHEMISTRY
Abstract

Background: We evaluated the safety and immunogenicity of (i) an intradermal HIV-DNA regimen given with/without intradermal electroporation (EP) as prime and (ii) the impact of boosting with modified vaccinia virus Ankara (HIV-MVA) administered with or without subtype C CN54rgp140 envelope protein adjuvanted with Glucopyranosyl Lipid A (GLA-AF) in volunteers from Tanzania and Mozambique. Methods: Healthy HIV-uninfected adults (N = 191) were randomized twice; first to one of three HIV-DNA intradermal priming regimens by needle-free ZetaJet device at weeks 0, 4 and 12 (Group I: 2x0.1mL [3mg/mL], Group II: 2x0.1mL [3mg/mL] plus EP, Group III: 1x0.1mL [6mg/mL] plus EP). Second the same volunteers received 108 pfu HIV-MVA twice, alone or combined with CN54rgp140/GLA-AF, intramuscularly by syringe, 16 weeks apart. Additionally, 20 volunteers received saline placebo. Results: Vaccinations and electroporation did not raise safety concerns. After the last vaccination, the overall IFN-γ ELISpot response rate to either Gag or Env was 97%. Intradermal electroporation significantly increased ELISpot response rates to HIV-DNA-specific Gag (66% group I vs. 86% group II, p = 0.026), but not to the HIV-MVA vaccine-specific Gag or Env peptide pools nor the magnitude of responses. Co-administration of rgp140/GLA-AF with HIV-MVA did not impact the frequency of binding antibody responses against subtype B gp160, C gp140 or E gp120 antigens (95%, 99%, 79%, respectively), but significantly enhanced the magnitude against subtype B gp160 (2700 versus 300, p<0.001) and subtype C gp140 (24300 versus 2700, p<0.001) Env protein. At relatively low titers, neutralizing antibody responses using the TZM-bl assay were more frequent in vaccinees given adjuvanted protein boost. Conclusion: Intradermal electroporation increased DNA-induced Gag response rates but did not show an impact on Env-specific responses nor on the magnitude of responses. Co-administration of HIV-MVA with rgp140/GLA-AF significantly enhanced antibody responses. [ABSTRACT FROM AUTHOR]

Published
2018
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19. Characterization of HIV-1 gp120 antibody specificities induced in anogenital secretions of RV144 vaccine recipients after late boost immunizations.

Author

Akapirat, Siriwat, Karnasuta, Chitraporn, Vasan, Sandhya, Rerks-Ngarm, Supachai, Pitisuttithum, Punnee, Madnote, Sirinan, Savadsuk, Hathairat, Rittiroongrad, Surawach, Puangkaew, Jiraporn, Phogat, Sanjay, Tartaglia, James, Sinangil, Faruk, de Souza, Mark S., Excler, Jean-Louis, Kim, Jerome H., Robb, Merlin L., Michael, Nelson L., Ngauy, Viseth, O'Connell, Robert J., and Karasavvas, Nicos

Subjects
ANTIBODY specificity, IMMUNOSPECIFICITY, IMMUNIZATION, VACCINATION, COMMUNICABLE diseases
Abstract

Sexual transmission is the principal driver of the human immunodeficiency virus (HIV) pandemic. Understanding HIV vaccine-induced immune responses at mucosal surfaces can generate hypotheses regarding mechanisms of protection, and may influence vaccine development. The RV144 (ClinicalTrials.gov NCT00223080) efficacy trial showed protection against HIV infections but mucosal samples were not collected, therefore, the contribution of mucosal antibodies to preventing HIV-1 acquisition is unknown. Here, we report the generation, magnitude and persistence of antibody responses to recombinant gp120 envelope and antigens including variable one and two loop scaffold antigens (gp70V1V2) previously shown to correlate with risk in RV144. We evaluated antibody responses to gp120 A244gD and gp70V1V2 92TH023 (both CRF01_AE) and Case A2 (subtype B) in cervico-vaginal mucus (CVM), seminal plasma (SP) and rectal secretions (RS) from HIV-uninfected RV144 vaccine recipients, who were randomized to receive two late boosts of ALVAC-HIV/AIDSVAX®B/E, AIDSVAX®B/E, or ALVAC-HIV alone at 0 and 6 months. Late vaccine boosting increased IgG geometric mean titers (GMT) to gp120 A244gD in AIDSVAX®B/E and ALVAC-HIV/AIDSVAX®B/E CVM (28 and 17 fold, respectively), followed by SP and RS. IgG to gp70V1V2 92TH023 increased in AIDSVAX®B/E and ALVAC-HIV/AIDSVAX®B/E CVM (11–17 fold) and SP (2 fold) two weeks post first boost. IgG to Case A2 was only detected in AIDSVAX®B/E and ALVAC-HIV/AIDSVAX®B/E CVM. Mucosal IgG to gp120 A244gD (CVM, SP, RS), gp70V1V2 92TH023 (CVM, SP), and Case A2 (CVM) correlated with plasma IgG levels (p<0.001). Although the magnitude of IgG responses declined after boosting, anti-gp120 A244gD IgG responses in CVM persisted for 12 months post final vaccination. Further studies in localization, persistence and magnitude of envelope specific antibodies (IgG and dimeric IgA) in anogenital secretions will help determine their role in preventing mucosal HIV acquisition. [ABSTRACT FROM AUTHOR]

Published
2018
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20. Sex and Urbanicity Contribute to Variation in Lymphocyte Distribution across Ugandan Populations

Author

Naluyima, Prossy, primary, Eller, Leigh Anne, additional, Ouma, Benson J., additional, Kyabaggu, Denis, additional, Kataaha, Peter, additional, Guwatudde, David, additional, Kibuuka, Hannah, additional, Wabwire-Mangen, Fred, additional, Robb, Merlin L., additional, Michael, Nelson L., additional, de Souza, Mark S., additional, Sandberg, Johan K., additional, and Eller, Michael A., additional

Published
2016
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21. Effect of rAd5-Vector HIV-1 Preventive Vaccines on HIV-1 Acquisition: A Participant-Level Meta-Analysis of Randomized Trials

Author

Huang, Yunda, primary, Follmann, Dean, additional, Nason, Martha, additional, Zhang, Lily, additional, Huang, Ying, additional, Mehrotra, Devan V., additional, Moodie, Zoe, additional, Metch, Barbara, additional, Janes, Holly, additional, Keefer, Michael C., additional, Churchyard, Gavin, additional, Robb, Merlin L., additional, Fast, Patricia E., additional, Duerr, Ann, additional, McElrath, M. Juliana, additional, Corey, Lawrence, additional, Mascola, John R., additional, Graham, Barney S., additional, Sobieszczyk, Magdalena E., additional, Kublin, James G., additional, Robertson, Michael, additional, Hammer, Scott M., additional, Gray, Glenda E., additional, Buchbinder, Susan P., additional, and Gilbert, Peter B., additional

Published
2015
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22. The Number and Complexity of Pure and Recombinant HIV-1 Strains Observed within Incident Infections during the HIV and Malaria Cohort Study Conducted in Kericho, Kenya, from 2003 to 2006

Author

Billings, Erik, primary, Sanders-Buell, Eric, additional, Bose, Meera, additional, Bradfield, Andrea, additional, Lei, Esther, additional, Kijak, Gustavo H., additional, Arroyo, Miguel A., additional, Kibaya, Rukia M., additional, Scott, Paul T., additional, Wasunna, Monique K., additional, Sawe, Frederick K., additional, Shaffer, Douglas N., additional, Birx, Deborah L., additional, McCutchan, Francine E., additional, Michael, Nelson L., additional, Robb, Merlin L., additional, Kim, Jerome H., additional, and Tovanabutra, Sodsai, additional

Published
2015
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23. HIV-DNA Given with or without Intradermal Electroporation Is Safe and Highly Immunogenic in Healthy Swedish HIV-1 DNA/MVA Vaccinees: A Phase I Randomized Trial

Author

Nilsson, Charlotta, primary, Hejdeman, Bo, additional, Godoy-Ramirez, Karina, additional, Tecleab, Teghesti, additional, Scarlatti, Gabriella, additional, Bråve, Andreas, additional, Earl, Patricia L., additional, Stout, Richard R., additional, Robb, Merlin L., additional, Shattock, Robin J., additional, Biberfeld, Gunnel, additional, Sandström, Eric, additional, and Wahren, Britta, additional

Published
2015
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24. Accuracy of Clinical Diagnosis of Dengue Episodes in the RV144 HIV Vaccine Efficacy Trial in Thailand

Author

Pitisuttithum, Punnee, primary, Rerks-Ngarm, Supachai, additional, Stablein, Donald, additional, Dawson, Peter, additional, Nitayaphan, Sorachai, additional, Kaewkungwal, Jaranit, additional, Michael, Nelson L., additional, Kim, Jerome H., additional, Robb, Merlin L., additional, O’Connell, Robert J., additional, Yoon, In-Kyu, additional, Fernandez, Stefan, additional, and Excler, Jean-Louis, additional

Published
2015
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25. Priming with a Simplified Intradermal HIV-1 DNA Vaccine Regimen followed by Boosting with Recombinant HIV-1 MVA Vaccine Is Safe and Immunogenic: A Phase IIa Randomized Clinical Trial

Author

Munseri, Patricia. J., primary, Kroidl, Arne, additional, Nilsson, Charlotta, additional, Joachim, Agricola, additional, Geldmacher, Christof, additional, Mann, Philipp, additional, Moshiro, Candida, additional, Aboud, Said, additional, Lyamuya, Eligius, additional, Maboko, Leonard, additional, Missanga, Marco, additional, Kaluwa, Bahati, additional, Mfinanga, Sayoki, additional, Podola, Lilly, additional, Bauer, Asli, additional, Godoy-Ramirez, Karina, additional, Marovich, Mary, additional, Moss, Bernard, additional, Hoelscher, Michael, additional, Gotch, Frances, additional, Stöhr, Wolfgang, additional, Stout, Richard, additional, McCormack, Sheena, additional, Wahren, Britta, additional, Mhalu, Fred, additional, Robb, Merlin L., additional, Biberfeld, Gunnel, additional, Sandström, Eric, additional, and Bakari, Muhammad, additional

Published
2015
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26. Potent Functional Antibody Responses Elicited by HIV-I DNA Priming and Boosting with Heterologous HIV-1 Recombinant MVA in Healthy Tanzanian Adults

Author

Joachim, Agricola, primary, Nilsson, Charlotta, additional, Aboud, Said, additional, Bakari, Muhammad, additional, Lyamuya, Eligius F., additional, Robb, Merlin L., additional, Marovich, Mary A., additional, Earl, Patricia, additional, Moss, Bernard, additional, Ochsenbauer, Christina, additional, Wahren, Britta, additional, Mhalu, Fred, additional, Sandström, Eric, additional, Biberfeld, Gunnel, additional, Ferrari, Guido, additional, and Polonis, Victoria R., additional

Published
2015
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27. Identification of Immunodominant CD4-Restricted Epitopes Co-Located with Antibody Binding Sites in Individuals Vaccinated with ALVAC-HIV and AIDSVAX B/E

Author

Ratto-Kim, Silvia, primary, de Souza, Mark S., additional, Currier, Jeffrey R., additional, Karasavvas, Nicos, additional, Sidney, John, additional, Rolland, Morgane, additional, Valencia-Micolta, Anais, additional, Madnote, Sirinan, additional, Sette, Alessandro, additional, Nitayaphan, Sorachai, additional, Pitisuttuthum, Punnee, additional, Kaewkungwal, Jaranit, additional, Rerks-Ngarm, Supachai, additional, O’Connell, Robert, additional, Michael, Nelson, additional, Robb, Merlin L., additional, Marovich, Mary, additional, and Kim, Jerome H., additional

Published
2015
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28. CD8 and CD4 Epitope Predictions in RV144: No Strong Evidence of a T-Cell Driven Sieve Effect in HIV-1 Breakthrough Sequences from Trial Participants

Author

Dommaraju, Kalpana, primary, Kijak, Gustavo, additional, Carlson, Jonathan M., additional, Larsen, Brendan B., additional, Tovanabutra, Sodsai, additional, Geraghty, Dan E., additional, Deng, Wenjie, additional, Maust, Brandon S., additional, Edlefsen, Paul T., additional, Sanders-Buell, Eric, additional, Ratto-Kim, Silvia, additional, deSouza, Mark S., additional, Rerks-Ngarm, Supachai, additional, Nitayaphan, Sorachai, additional, Pitisuttihum, Punnee, additional, Kaewkungwal, Jaranit, additional, O'Connell, Robert J., additional, Robb, Merlin L., additional, Michael, Nelson L., additional, Mullins, James I., additional, Kim, Jerome H., additional, and Rolland, Morgane, additional

Published
2014
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31. Plasma IgG to Linear Epitopes in the V2 and V3 Regions of HIV-1 gp120 Correlate with a Reduced Risk of Infection in the RV144 Vaccine Efficacy Trial

Author

Gottardo, Raphael, primary, Bailer, Robert T., additional, Korber, Bette T., additional, Gnanakaran, S., additional, Phillips, Joshua, additional, Shen, Xiaoying, additional, Tomaras, Georgia D., additional, Turk, Ellen, additional, Imholte, Gregory, additional, Eckler, Larry, additional, Wenschuh, Holger, additional, Zerweck, Johannes, additional, Greene, Kelli, additional, Gao, Hongmei, additional, Berman, Phillip W., additional, Francis, Donald, additional, Sinangil, Faruk, additional, Lee, Carter, additional, Nitayaphan, Sorachai, additional, Rerks-Ngarm, Supachai, additional, Kaewkungwal, Jaranit, additional, Pitisuttithum, Punnee, additional, Tartaglia, James, additional, Robb, Merlin L., additional, Michael, Nelson L., additional, Kim, Jerome H., additional, Zolla-Pazner, Susan, additional, Haynes, Barton F., additional, Mascola, John R., additional, Self, Steve, additional, Gilbert, Peter, additional, and Montefiori, David C., additional

Published
2013
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32. Analysis of V2 Antibody Responses Induced in Vaccinees in the ALVAC/AIDSVAX HIV-1 Vaccine Efficacy Trial

Author

Zolla-Pazner, Susan, primary, deCamp, Allan C., additional, Cardozo, Timothy, additional, Karasavvas, Nicos, additional, Gottardo, Raphael, additional, Williams, Constance, additional, Morris, Daryl E., additional, Tomaras, Georgia, additional, Rao, Mangala, additional, Billings, Erik, additional, Berman, Phillip, additional, Shen, Xiaoying, additional, Andrews, Charla, additional, O'Connell, Robert J., additional, Ngauy, Viseth, additional, Nitayaphan, Sorachai, additional, de Souza, Mark, additional, Korber, Bette, additional, Koup, Richard, additional, Bailer, Robert T., additional, Mascola, John R., additional, Pinter, Abraham, additional, Montefiori, David, additional, Haynes, Barton F., additional, Robb, Merlin L., additional, Rerks-Ngarm, Supachai, additional, Michael, Nelson L., additional, Gilbert, Peter B., additional, and Kim, Jerome H., additional

Published
2013
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33. Heterologous Prime-Boost Regimens Using rAd35 and rMVA Vectors Elicit Stronger Cellular Immune Responses to HIV Proteins Than Homologous Regimens

Author

Ratto-Kim, Silvia, primary, Currier, Jeffrey R., additional, Cox, Josephine H., additional, Excler, Jean-Louis, additional, Valencia-Micolta, Anais, additional, Thelian, Doris, additional, Lo, Vicky, additional, Sayeed, Eddy, additional, Polonis, Victoria R., additional, Earl, Patricia L., additional, Moss, Bernard, additional, Robb, Merlin L., additional, Michael, Nelson L., additional, Kim, Jerome H., additional, and Marovich, Mary A., additional

Published
2012
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34. Safety and Reactogenicity of Canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E Vaccination in an Efficacy Trial in Thailand

Author

Pitisuttithum, Punnee, primary, Rerks-Ngarm, Supachai, additional, Bussaratid, Valai, additional, Dhitavat, Jittima, additional, Maekanantawat, Wirach, additional, Pungpak, Swangjai, additional, Suntharasamai, Pravan, additional, Vanijanonta, Sirivan, additional, Nitayapan, Sorachai, additional, Kaewkungwal, Jaranit, additional, Benenson, Michael, additional, Morgan, Patricia, additional, O'Connell, Robert J., additional, Berenberg, Jeffrey, additional, Gurunathan, Sanjay, additional, Francis, Donald P., additional, Paris, Robert, additional, Chiu, Joseph, additional, Stablein, Donald, additional, Michael, Nelson L., additional, Excler, Jean-Louis, additional, Robb, Merlin L., additional, and Kim, Jerome H., additional

Published
2011
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35. A Double-Blind Randomized Phase I Clinical Trial Targeting ALVAC-HIV Vaccine to Human Dendritic Cells

Author

Eller, Michael A., primary, Slike, Bonnie M., additional, Cox, Josephine H., additional, Lesho, Emil, additional, Wang, Zhining, additional, Currier, Jeffrey R., additional, Darden, Janice M., additional, Polonis, Victoria R., additional, Vahey, Maryanne T., additional, Peel, Sheila, additional, Robb, Merlin L., additional, Michael, Nelson L., additional, and Marovich, Mary A., additional

Published
2011
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36. B Cell Depletion in HIV-1 Subtype A Infected Ugandan Adults: Relationship to CD4 T Cell Count, Viral Load and Humoral Immune Responses

Author

Oballah, Peter, primary, Flach, Britta, additional, Eller, Leigh A., additional, Eller, Michael A., additional, Ouma, Benson, additional, de Souza, Mark, additional, Kibuuka, Hannah N., additional, Wabwire-Mangen, Fred, additional, Brown, Bruce K., additional, Michael, Nelson L., additional, Robb, Merlin L., additional, Montefiori, David, additional, and Polonis, Victoria R., additional

Published
2011
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37. Innate and Adaptive Immune Responses Both Contribute to Pathological CD4 T Cell Activation in HIV-1 Infected Ugandans

Author

Eller, Michael A., primary, Blom, Kim G., additional, Gonzalez, Veronica D., additional, Eller, Leigh Anne, additional, Naluyima, Prossy, additional, Laeyendecker, Oliver, additional, Quinn, Thomas C., additional, Kiwanuka, Noah, additional, Serwadda, David, additional, Sewankambo, Nelson K., additional, Tasseneetrithep, Boonrat, additional, Wawer, Maria J., additional, Gray, Ronald H., additional, Marovich, Mary A., additional, Michael, Nelson L., additional, de Souza, Mark S., additional, Wabwire-Mangen, Fred, additional, Robb, Merlin L., additional, Currier, Jeffrey R., additional, and Sandberg, Johan K., additional

Published
2011
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38. Phase I Safety and Immunogenicity Evaluation of MVA-CMDR, a Multigenic, Recombinant Modified Vaccinia Ankara-HIV-1 Vaccine Candidate

Author

Currier, Jeffrey R., primary, Ngauy, Viseth, additional, de Souza, Mark S., additional, Ratto-Kim, Silvia, additional, Cox, Josephine H., additional, Polonis, Victoria R., additional, Earl, Patricia, additional, Moss, Bernard, additional, Peel, Sheila, additional, Slike, Bonnie, additional, Sriplienchan, Somchai, additional, Thongcharoen, Prasert, additional, Paris, Robert M., additional, Robb, Merlin L., additional, Kim, Jerome, additional, Michael, Nelson L., additional, and Marovich, Mary A., additional

Published
2010
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39. Phase I Study of Safety and Immunogenicity of an Escherichia coli-Derived Recombinant Protective Antigen (rPA) Vaccine to Prevent Anthrax in Adults

Author

Brown, Bruce K., primary, Cox, Josephine, additional, Gillis, Anita, additional, VanCott, Thomas C., additional, Marovich, Mary, additional, Milazzo, Mark, additional, Antonille, Tanya Santelli, additional, Wieczorek, Lindsay, additional, McKee, Kelly T., additional, Metcalfe, Karen, additional, Mallory, Raburn M., additional, Birx, Deborah, additional, Polonis, Victoria R., additional, and Robb, Merlin L., additional

Published
2010
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41. High-Throughput High-Resolution Class I HLA Genotyping in East Africa

Author

Koehler, Rebecca N., primary, Walsh, Anne M., additional, Sanders-Buell, Eric E., additional, Eller, Leigh Anne, additional, Eller, Michael, additional, Currier, Jeffrey R., additional, Bautista, Christian T., additional, Wabwire-Mangen, Fred, additional, Hoelscher, Michael, additional, Maboko, Leonard, additional, Kim, Jerome, additional, Michael, Nelson L., additional, Robb, Merlin L., additional, McCutchan, Francine E., additional, and Kijak, Gustavo H., additional

Published
2010
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42. Contraceptive Use in Women Enrolled into Preventive HIV Vaccine Trials: Experience from a Phase I/II Trial in East Africa

Author

Kibuuka, Hannah, primary, Guwatudde, David, additional, Kimutai, Robert, additional, Maganga, Lucas, additional, Maboko, Leonard, additional, Watyema, Cecilia, additional, Sawe, Fredrick, additional, Shaffer, Douglas, additional, Matsiko, Dickson, additional, Millard, Monica, additional, Michael, Nelson, additional, Wabwire-Mangen, Fred, additional, and Robb, Merlin, additional

Published
2009
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43. Reference Intervals in Healthy Adult Ugandan Blood Donors and Their Impact on Conducting International Vaccine Trials

Author

Eller, Leigh Anne, primary, Eller, Michael A., additional, Ouma, Benson, additional, Kataaha, Peter, additional, Kyabaggu, Denis, additional, Tumusiime, Richard, additional, Wandege, Joseph, additional, Sanya, Ronald, additional, Sateren, Warren B., additional, Wabwire-Mangen, Fred, additional, Kibuuka, Hannah, additional, Robb, Merlin L., additional, Michael, Nelson L., additional, and de Souza, Mark S., additional

Published
2008
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45. Relatively Low HIV Infection Rates in Rural Uganda, but with High Potential for a Rise: A Cohort Study in Kayunga District, Uganda.

Author

Guwatudde, David, Wabwire-Mangen, Fred, Eller, Leigh Anne, Eller, Michael, McCutchan, Francine, Kibuuka, Hannah, Millard, Monica, Sewankambo, Nelson, Serwadda, David, Michael, Nelson, and Robb, Merlin

Subjects
HIV infections, HIV, COHORT analysis, STANDARD deviations, LABORATORIES, METHODOLOGY, SEXUAL consent, SEXUAL ethics
Abstract

Background: Few studies have been conducted in Uganda to identify and quantify the determinants of HIV-1 infection. We report results from a community-based cohort study, whose primary objectives were to determine HIV-1 prevalence, incidence, and determinants of these infections, among other objectives. Methodology: Consenting volunteers from the rural district of Kayunga in Uganda aged 15-49 years were enrolled between March and July 2006. Participants were evaluated every six months. A questionnaire that collected information on behavioral and other HIV-1 risk factors was administered, and a blood sample obtained for laboratory analysis at each study visit. Principal Findings: HIV-1 prevalence among the 2025 participants was 9.9% (95% CI = 8.6%-11.2%). By the end of 12 months of follow-up, 1689.7 person-years had been accumulated, with a median follow-up time of 11.97 months. Thirteen HIV-1 incident cases were detected giving an annual HIV-1 incidence of 0.77% (95% CI = 0.35-1.19). Prevalence of HSV-2 infection was 57% and was strongly associated with prevalent HIV-1 infection (adjusted Odds Ratio = 3.9, 95% CI = 2.50-6.17); as well as incident HIV-1 infection (adjusted Rate Ratio (RR) = 8.7, 95% CI = 1.11-67.2). The single most important behavioral characteristic associated with incident HIV infection was the number of times in the past 6 months, a participant had sex with person(s) they suspected/knew were having sex with others; attaining statistical significance at 10 times and higher (adjusted RR = 6.3, 95% CI = 1.73-23.1). By the end of 12 months of follow-up, 259 participants (13%) were lost to follow-up, 13 (0.6%) had died, and 2 (0.1%) had withdrawn consent. Conclusions: Despite relatively low HIV-1 incidence observed in this community, prevalence remains relatively high. In the presence of high prevalence of HSV-2 infection and the behavioral characteristic of having sex with more than one partner, there is potential for increase in HIV-1 incidence. [ABSTRACT FROM AUTHOR]

Published
2009
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