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| Name | Class |
|---|---|
| CONRAD | OTHER |
| Gilead Sciences | INDUSTRY |
| FHI 360 | OTHER |
| Institute for Healthcare Improvement |
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The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.
The CAPRISA 008 trial is a two-arm, open-label, randomized controlled trial that is being conducted at the CAPRISA eThekwini and CAPRISA Vulindlela Clinics and their neighboring public sector family planning services in KwaZulu-Natal, South Africa. Up to 700 consenting sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral (ARV) prevention study will be enrolled and followed for a maximum 30 months. All women will be provided with 1% tenofovir gel but will be randomised to either receive their gel through a public sector family planning services with 2-3 monthly provision (intervention arm) or through the CAPRISA research clinics with monthly provision (control arm).
All women in the trial will be provided with the standard package of HIV prevention and reproductive health services. Participants in both study arms will be provided with a supply of single-use, pre-filled applicators of 1% tenofovir gel. While in the study, participants will be advised and supported to follow the CAPRISA 004 pre- and post-dosing strategy, namely BAT24, where the first dose of tenofovir gel is applied within 12 hours before anticipated coitus and a second dose as soon as possible but within 12 hours after coitus, with a maximum of two doses of gel in a 24-hour period.
The primary objective of this trial is to assess the effectiveness of an implementation model for tenofovir gel provision through family planning services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery |
|
| Control | Active Comparator | monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% tenofovir gel | Drug | Participants will be randomized to receive 1% tenofovir gel through either:
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) | The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for >120 days. | Between 2012 to 2015, up to 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Incidence Rates | Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quarraisha Abdool Karim, PhD | Centre for the AIDS Programme of Research in South Africa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAPRISA eThekwini Clinical Research Site | Durban | KwaZulu-Natal | 4001 | South Africa | ||
| CAPRISA Vulindlela Clinical Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20643915 | Background | Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19. | |
| 28348164 |
| Label | URL |
|---|---|
| Centre for the AIDS Programme of Research in South Africa web site | View source |
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448 were assessed for eligibility and 382 were randomized. However, only 372 were eligible for study participation. Of the 10 who were ineligibly enrolled: 6 were HIV positive at enrollment, 2 were co-enrolled in another trial, 1 had no post-randomization follow-up data and 1 was pregnant at enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
|
| FG001 | Control | monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to treat population was analyzed. All participants who were randomized and met the pre-enrollment eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) | The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for >120 days. | Intent to treat population and the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days). | Posted | Least Squares Mean | 95% Confidence Interval | Used gel applicators per month | Between 2012 to 2015, up to 28 months |
Between 2012 and 2015, up to 28 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
The 2-3 monthly intervals between clinic appointments in the control arm is likely to introduce recall bias in this arm, unlike the monthly intervals in the intervention arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nonhlanhla Yende-Zuma | CAPRISA | +27 31 260 4392 | nonhlanhla.yende@caprisa.org |
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| OTHER |
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|
| Between 2012 and 2015, up to 28 months |
| Pregnancy Incidence Rates | Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one. | Between 2012 and 2015, up to 28 months |
| Percentage of Participants Achieving Adherence >80%. | Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30. | Between 2012 and 2015, up to 28 months |
| HIV Viral Load Among HIV Seroconverters | This is mean log transformed HIV viral load measured at the first visit post HIV infection. | Between 2012 and 2015, up to 28 months |
| Tenofovir Resistance Among HIV Seroconverters | Between 2012 and 2015, up to 28 months |
| Human Papillomavirus Incidence Rates | For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test. | Between 2012 and 2015, up to 28 months |
| Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up | Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable. | All participants with drug levels at 12 months of follow-up |
| Product Acceptability | This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire. | At study completion, up to 28 months |
| Pietermaritzburg |
| KwaZulu-Natal |
| South Africa |
| Derived |
| Mngadi KT, Singh JA, Mansoor LE, Wassenaar DR. Undue inducement: a case study in CAPRISA 008. J Med Ethics. 2017 Dec;43(12):824-828. doi: 10.1136/medethics-2016-103414. Epub 2017 Mar 27. |
| 25527071 | Derived | Mansoor LE, Abdool Karim Q, Mngadi KT, Dlamini S, Montague C, Nkomonde N, Mvandaba N, Baxter C, Gengiah TN, Samsunder N, Dawood H, Grobler A, Frohlich JA, Abdool Karim SS. Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial. Trials. 2014 Dec 19;15:496. doi: 10.1186/1745-6215-15-496. |
| Withdrawal by Subject |
|
| Relocated |
|
| Investigator decision |
|
| BG001 | Control | monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sex acts in past 30 days | Median | Inter-Quartile Range | Acts |
|
| Contraception | Count of Participants | Participants |
|
| HSV-2 prevalence | A total of 9 participants had equivocal results and 2 had missing results. | Count of Participants | Participants |
|
| HPV prevalence | Total of 5 participants had equivocal and 2 had missing results. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Intervention | 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
|
| OG001 | Control | monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
|
|
|
|
| Secondary | HIV Incidence Rates | Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one. | Intent to treat population(all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data). | Posted | Number | 95% Confidence Interval | Incidence rate/100 women years | Between 2012 and 2015, up to 28 months |
|
|
|
|
| Secondary | Pregnancy Incidence Rates | Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one. | Intent to treat population(all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data). | Posted | Number | 95% Confidence Interval | Incidence rate/100 women years | Between 2012 and 2015, up to 28 months |
|
|
|
|
| Secondary | Percentage of Participants Achieving Adherence >80%. | Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30. | This is a subset of intent to treat population. It includes all participants who returned used gel applicators and also reported sex during follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | Between 2012 and 2015, up to 28 months |
|
|
|
|
| Secondary | HIV Viral Load Among HIV Seroconverters | This is mean log transformed HIV viral load measured at the first visit post HIV infection. | All participants who became HIV infected | Posted | Mean | Standard Deviation | log10 copies/ml | Between 2012 and 2015, up to 28 months |
|
|
|
|
| Secondary | Tenofovir Resistance Among HIV Seroconverters | Due to lack of funding, tenofovir resistance testing was not done in this study. However, we do have stored samples to fall back onto, should we secure funding. | Posted | Between 2012 and 2015, up to 28 months |
|
|
| Secondary | Human Papillomavirus Incidence Rates | For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test. | This is the subset of intent to treat population. It includes all participants who had HPV negative results at randomisation. | Posted | Number | 95% Confidence Interval | Incidence rate/100 women years | Between 2012 and 2015, up to 28 months |
|
|
|
|
| Secondary | Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up | Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable. | All participants with drug levels measured at 12 months of follow-up | Posted | Number | 95% Confidence Interval | percentage of participants | All participants with drug levels at 12 months of follow-up |
|
|
|
|
| Secondary | Product Acceptability | This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire. | Participants who completed product acceptability questionnaire at study exit | Posted | Count of Participants | Participants | At study completion, up to 28 months |
|
|
|
| 0 |
| 189 |
| 13 |
| 189 |
| 166 |
| 189 |
| EG001 | Control | monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics 1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:
| 2 | 183 | 17 | 183 | 181 | 183 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Anal sphincter atony | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Post procedural sepsis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Investigation | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Soft tissue mass | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Ameloblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Complication of pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
|
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Anoplasty | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Vulvovaginitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Genital ulceration | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Sterilized |
|