Abstract:
BACKGROUND:The success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results. OBJECTIVE:This paper describes the challenges and specific strategies used to retain participants in a Phase 2B safety and effectiveness study of daily oral and vaginal tenofovir formulations for the prevention of HIV-1 infection in the MTN-003 (VOICE) trial in Kampala, Uganda. METHODS:Once enrolled, participants were seen every 28 days at the research site and their study product was re-filled. Challenges to retention included a mobile population, non-disclosure of study participation to spouse/family, and economic constraints. Strategies used to maintain high participation rates included the use of detailed locator information, a participant tracking database, regular HIV/STI testing, and the formation of close bonds between staff and subjects. RESULTS:We enrolled 322 women out of the 637 screened. The overall retention rate was 95% over a 3 year follow up period. Only 179 (3%) out of the 6124 expected visits were missed throughout study implementation. Reasons for missed visits included: participants thinking that they did not need frequent visits due to their HIV negative status, time constraints due to commercial sex work, and migration for better employment. CONCLUSIONS:With the implementation of multi-faceted comprehensive follow-up and retention strategies, we achieved very high retention rates in the MTN-003 study. This paper provides a blueprint for effective participant retention strategies for other longitudinal HIV prevention studies in resource-limited settings in Sub-Saharan Africa.
journal_name
HIV Clin Trialsjournal_title
HIV clinical trialsauthors
Wynne J,Muwawu R,Mubiru MC,Kamira B,Kemigisha D,Nakyanzi T,Kabwigu S,Nakabiito C,Kiweewa Matovu Fdoi
10.1080/15284336.2018.1513711subject
Has Abstractpub_date
2018-10-01 00:00:00pages
165-171issue
5eissn
1528-4336issn
1945-5771journal_volume
19pub_type
杂志文章,多中心研究,随机对照试验abstract:PURPOSE:To characterize the steady-state pharmacokinetic combination of the nonpeptidic protease inhibitor tipranavir (TPV) with ritonavir (RTV) in 95 healthy adult volunteers, a phase 1, single-center, open-label, randomized, parallel-group trial was conducted. METHOD:Participants received 250-mg self-emulsifying dru...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1310/RRX7-49ME-27V7-MWWV
更新日期:2004-11-01 00:00:00
abstract:BACKGROUND:Immune response rates following influenza vaccination are often lower in HIV-infected individuals. Low vitamin D levels were correlated with weak immune response in cancer patients and are known to be lower in HIV-infected patients. METHODS:Diagnostic study to determine immune response against the H1N1v com...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1404-175
更新日期:2013-07-01 00:00:00
abstract:BACKGROUND:Impaired allostimulatory function of dendritic cells in patients with AIDS has been reported previously. Granulocyte-macrophage colony-stimulating factor (GM-CSF) can restore the T-cell stimulatory function in transforming growth factor-beta 1 (TGF-beta 1)-inhibited murine accessory cells. We now report the ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/HP8B-NF27-VFWA-80YX
更新日期:2002-05-01 00:00:00
abstract:INTRODUCTION:It is not uncommon for patients with HIV infection to miss scheduled visits in outpatient clinics without justifying the failure to appear or reschedule the appointment. Few studies have assessed the impact of inconsistent follow-ups on resource use and disease outcomes in this patient population. OBJECTI...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1305-289
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:The best method for assessment of functional status in human immunodeficiency virus type 1 (HIV-1) infected persons is unknown. OBJECTIVE:We hypothesized that 3 instruments to assess frailty or disability in elderly populations would perform similarly in HIV-1-infected persons. METHODS:HIV-infected subject...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1306-324
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:Unannounced home-based pill counts conducted in person or on the telephone are reliable and valid for monitoring medication adherence. However, expecting to have one's pills counted, organizing medications for pill counts, and increased attention from the person conducting the pill counts may have reactive e...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/hct1106-325
更新日期:2010-11-01 00:00:00
abstract:PURPOSE:To assess the effect of changing antiretroviral therapy in patients initially treated with saquinavir hard gel capsule (hgc). METHOD:A retrospective cohort study comparing the virological and immunological responses in antiretroviral-naïve patients initially treated with a regimen of saquinavir-hgc, zidovudine...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/KED4-8TW3-4ARG-HFC5
更新日期:2001-03-01 00:00:00
abstract::Three HIV individuals with chronic hepatitis C presented with esophageal variceal bleeding. They had mild liver fibrosis and normal liver function tests. All had received didanosine for long periods. Noncirrhotic portal hypertension associated with didanosine may appear in HIV patients without any liver disease or add...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0906-440
更新日期:2008-11-01 00:00:00
abstract:PURPOSE:To assess the virologic and immunologic response to a boosted double-protease inhibitor (PI) regimen of highly pretreated patients infected with HIV-1 and to examine the role of PI resistance and concentration of serum saquinavir. METHOD:In an open-label prospective study, lopinavir/ritonavir, saquinavir-sgc, ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/HAG3-8YA5-UDQC-36NX
更新日期:2005-03-01 00:00:00
abstract:BACKGROUND:Multiple resistance to nucleoside analogs mediated by the Q151M complex and/or codon 67-69 inserts/deletions represents a growing problem among HIV-infected persons, most of whom have been exposed to sequential therapies for long periods of time. PATIENTS AND METHOD:All plasma samples collected from HIV-inf...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/X618-KWKJ-WCTQ-LQ2L
更新日期:2003-11-01 00:00:00
abstract:BACKGROUND:Despite the high prevalence of HIV in correctional settings, the duration of therapy and response to various highly active antiretroviral therapy (HAART) regimens in this setting is unknown. METHOD:Using a retrospective cohort study (1997-2002) of HIV-infected prisoners in Connecticut that linked demographi...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0804-205
更新日期:2007-07-01 00:00:00
abstract:PURPOSE:The objectives of this study were to determine the prevalence of osteopenia and the factors associated with its presence in HIV-infected patients under highly active antiretroviral therapy (HAART) and to assess the changes of bone mineral density (BMD) in a population followed prospectively. METHOD:BMD was ass...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/4X0H-UVMJ-BHYW-CPFB
更新日期:2003-09-01 00:00:00
abstract:PURPOSE:To investigate the factors that contribute to willingness to participate in HIV clinical trials and to determine the impact of a brief intervention on willingness to participate. METHODS:115 consecutive outpatients receiving HIV primary care participated in this prospective study. Each patient completed a ques...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1002-104
更新日期:2009-03-01 00:00:00
abstract:PURPOSE:To prospectively determine incidence, prevalence, and extent of lipodystrophy (LD) and associated metabolic changes. METHOD:This was a prospective cohort study. Body habitus changes were determined by anthropometrics, photography, and regional dual-energy X-ray absorptiometry (DXA) scan. Metabolic parameters i...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0905-314
更新日期:2008-09-01 00:00:00
abstract:BACKGROUND:To improve the dosing frequency and pill burden of antiretroviral therapy, we compared two once-daily dosed regimens to a twice-daily dosed regimen. METHOD:HIV-1-infected, antiretroviral drug-naïve adults were randomized to either twice-daily nelfinavir and stavudine and once-daily didanosine (regimen A) or...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/A686-M37Y-J2PT-E9GJ
更新日期:2005-09-01 00:00:00
abstract:BACKGROUND:Nevirapine, a nonnucleoside analogue, has demonstrated suppression of human immunodeficiency virus (HIV) replication alone and in combination therapy. However, the durable suppression of HIV with nevirapine when used along with other nucleosides in HIV-infected patients who are treated in clinical practice n...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1310/4nb4-1gx6-4xvk-pbgl
更新日期:2003-07-01 00:00:00
abstract::When prescribed appropriately and taken adherently, antiretroviral therapy can consistently and durably suppress HIV replication, potentially translating into years of near normal health for HIV-infected persons. However, presently available antiretrovirals are associated with a cluster of physical and metabolic sympt...
journal_title:HIV clinical trials
pub_type: 杂志文章,评审
doi:10.1310/XP75-7VJ5-HML2-YF1W
更新日期:2004-05-01 00:00:00
abstract:PURPOSE:Proven clinical efficacy of protease-sparing regimens (PSR) has been shown. Concerns exist about broad applicability of these regimens in advanced naïve patients. Recent reports have associated a rise in liver enzymes with nevi rapine; however, no data exist with efavirenz. METHOD:17 consecutive antiretroviral...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/2V0B-HDWC-AGWR-H56M
更新日期:2001-01-01 00:00:00
abstract:OBJECTIVES:ARTEMIS demonstrated significantly greater efficacy of once-daily darunavir/ritonavir (DRV/r) 800/100 mg versus lopinavir/ritonavir 800/200 mg (total daily dose) in treatment-naïve, HIV-1-infected patients at week 96. The influence of baseline characteristics on efficacy and safety was analyzed in DRV/r pati...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/hct1206-313
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:Raltegravir (RAL) constitutes the first available integrase strand transfer inhibitor (INSTI) available in clinical practice. Three independent pathways have been described to confer resistance to RAL. Secondary mutations with little effect on INSTI susceptibility and additional substitutions with an uncerta...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1310/hct1401-10
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND:Exercise training has been shown to be an effective strategy to balance oxidative stress status; however, this is underexplored in people living with HIV/AIDS (PLWHA). OBJECTIVE:To evaluate the effects of exercise training on oxidative stress in PLWHA receiving antiretroviral therapy. METHODS:Patients perf...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1080/15284336.2018.1481247
更新日期:2018-08-01 00:00:00
abstract:PURPOSE:The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients. METHOD:We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1310/brbv-3941-h1pp-ndry
更新日期:2003-03-01 00:00:00
abstract:BACKGROUND:Simple antiretroviral drug combinations might provide a comparable benefit to standard triple regimens in patients with mild HIV disease, because poor adherence and toxicities often compromise the sustained benefit of the latest triple regimens, especially when protease inhibitors are used. Bad adherence is ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1310/FAJF-7A8G-QAR4-Q0X5
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:Endothelial progenitor cells (EPCs) are bone marrow-derived cells that contribute to vascular repair. EPCs may be reduced in HIV-infected (HIV+) persons, contributing to cardiovascular disease (CVD). Telmisartan is an angiotensin receptor blocker that increases EPCs in HIV-uninfected adults. OBJECTIVE:To as...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1080/15284336.2016.1234222
更新日期:2016-11-01 00:00:00
abstract:BACKGROUND:Perinatally acquired HIV-infected (PaHIV) young adults undergo neurodevelopment in the presence of HIV infection and antiretroviral therapy, which may lead to neurocognitive (NC) impairment. Knowledge of NC function in this group is sparse and control data lacking. We compared cerebral function in young adul...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1179/1528433614Z.0000000003
更新日期:2015-03-01 00:00:00
abstract:PURPOSE:Questionnaires assessing patient-reported outcomes in HIV are either too long or not HIV-specific. Our aim was to develop and validate a simplified HIV patient questionnaire. METHOD:607 HIV patients treated with a combination of antiretroviral (ARV) drugs were enrolled in an observational, longitudinal study. ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1004-215
更新日期:2009-07-01 00:00:00
abstract:BACKGROUND:Some individuals control HIV replication without antiretroviral (ARV) therapy. OBJECTIVE:To analyze viral suppression in young women in rural South Africa enrolled in a trial evaluating a behavioral intervention for HIV prevention. METHODS:Plasma samples were obtained from women ages 13-24 (81 infected at ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1080/15284336.2018.1531534
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed. OBJECTIVE:To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care. METHODS:A rando...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/hct1405-235
更新日期:2013-09-01 00:00:00
abstract:PURPOSE:We obtained peripheral blood monocytes from HIV-1-infected patients and differentiated them into macrophages in vitro to investigate the contribution of purified monocytes to plasma viremia in HIV-infected patients. METHOD:We compared the production of HIV-1 from purified monocytes isolated from patients who w...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/EF26-V3PC-AG5X-FCF4
更新日期:2002-11-01 00:00:00
abstract:METHOD:Analysis of virological, immunological, and clinical data over 24 weeks of treatment of drug-experienced patients administered didanosine (ddI) and tenofovir (TDF) plus either PI or NNRTI (17 patients) compared to 14 patients on ddI plus lamivudine and to 19 patients on ddI plus stavudine. RESULTS:Patients trea...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/0B0R-J1LP-KQPF-43HB
更新日期:2006-01-01 00:00:00