PrEP Demonstration Study in Swaziland
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| ClinicalTrials.gov Identifier: NCT03254550 |
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Recruitment Status :
Completed
First Posted : August 18, 2017
Last Update Posted : July 11, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Negative People Identified at Substantial Risk for HIV Infection | Other: PrEP Promotion Package | Not Applicable |
The study will assess who will be reached with an introduction to and an offer of PrEP - and who will take up PrEP - when PrEP becomes available through different delivery points in the public-sector health system, including outpatient department (OPD), antenatal care (ANC), postnatal care (PNC) , family planning (FP) , and following HIV counseling and testing (VCT).
In addition to PrEP reach and PrEP uptake, the study aims to establish PrEP retention and average costs per client, by different health systems delivery points and to assess the effectiveness of a feasible and low-cost PrEP Promotion Package (PPP). The exact composition of PPP will be informed by findings from in-depth- interviews with clients, providers, and PrEP stakeholders. The effect of the PPP on the monthly number of clients who are initiated on PrEP will be studied using a stepped-wedge cluster-randomized design. Specifically, the trial will have two sequences with three healthcare facilities in each sequence, and three periods. In the first period, all healthcare facilities will be in the control phase; in the second period three healthcare facilities will implement the PPP; and in the third period all six healthcare facilities will implement the PPP.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 517 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a stepped-wedge randomized design (there was no option for stepped-wedge design in the drop-down menu) with two sequences (each consisting of three healthcare facilities) and three periods. |
| Masking: | None (Open Label) |
| Masking Description: | Healthcare facilities will not be informed as to when they are expected to start implementing the intervention (the PrEP Promotion Package) until two weeks prior to the start of the intervention phase. |
| Primary Purpose: | Health Services Research |
| Official Title: | Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland |
| Actual Study Start Date : | August 1, 2017 |
| Actual Primary Completion Date : | January 31, 2019 |
| Actual Study Completion Date : | March 2, 2019 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control phase
This is the provision of PrEP without the use of the PrEP Promotion Package. PrEP promotion in the control phase consists of each clinic displaying posters that advertise PrEP, pamphlets, and palm cards that patients can take home from the clinic.
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Experimental: Intervention phase
This is the provision of PrEP as in the control phase plus the addition of five PrEP promotion components, which constitute the PrEP Promotion Package (PPP). These five additions are: 1) a PrEP promotion video to be played in the waiting room, 2) T-shirts advertising PrEP to be worn by healthcare workers, iii) a flipchart to support healthcare workers' PrEP counseling, iv) an informational booklet for clients to take home, and v) self-risk assessment forms to be displayed in the waiting room.
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Other: PrEP Promotion Package
A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge |
- Uptake [ Time Frame: 18 months ]The monthly number of clients who was initiated on PrEP
- Risk assessment [ Time Frame: 18 months ]The monthly number of clients who underwent a risk assessment for PrEP eligibility
- Substantial risk [ Time Frame: 18 months ]The monthly number of clients who was identified as being at a substantial risk of acquiring HIV
- Acceptance conditional on risk [ Time Frame: 18 months ]% of HIV-negative clients at substantial risk for HIV infection who accepted a PrEP offer
- Linkage [ Time Frame: 12 months ]The monthly number of clients who either took up PrEP or were linked to antiretroviral therapy
- Retention at 6 months [ Time Frame: 6 months ]% of clients taking PrEP who were retained at six months after PrEP initiation. Retention was defined as attending all follow-up visits during the first 180 days after PrEP initiation not more than seven days after the scheduled appointment.
- HIV incidence [ Time Frame: 18 month ]% of clients initiated on PrEP who seroconverted during the first six months after taking up PrEP.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Confirmed HIV negative by rapid antibody test following the National HIV testing services (HTS) algorithm on the day of PrEP initiation
- > 16 years of age
- Willing and able to provide written informed consent
- Identified at substantial risk of acquiring HIV infection
- No current or recent illness (within past month) consistent with acute HIV infection in combination with a preceding high risk exposure for HIV
- No contraindications to the use of Tenofovir(TDF)/Lamivudine (3TC)
- Ready to adhere to PrEP and willing to attend the follow up evaluations including repeat HIV testing and monitoring for side-effects
Exclusion Criteria:
- Younger than 16 years of age
- Currently having symptoms of acute HIV infection
- Suspicion of window period following a potential exposure to HIV
- Body weight < 40 kg
- Creatinine clearance <60 ml/min
- Using other nephrotoxic drugs (e.g. aminoglycosides)
- Not willing to come for follow up visits every 3 months which will include HIV testing and counselling and monitoring for side-effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254550
| Swaziland | |
| Hhukwini Clinic | |
| Hhukwini, Hhohho Region, Swaziland | |
| Horo Clini | |
| Horo, Hhohho Region, Swaziland | |
| Ndzingeni Nazarene Clinic | |
| Ndzingeni, Hhohho Region, Swaziland | |
| Nfontjeni Clinic | |
| Nfontjeni, Hhohho Region, Swaziland | |
| Siphocosini Clinic | |
| Siphocosini, Hhohho Region, Swaziland | |
| Ndvwabangeni Nazarene Clinic | |
| Ndvwabangeni, Hhohho, Swaziland | |
| Principal Investigator: | Sindy Matse, MPH | Eswatini National AIDS Program |
Documents provided by Clinton Health Access Initiative Inc.:
| Responsible Party: | Clinton Health Access Initiative Inc. |
| ClinicalTrials.gov Identifier: | NCT03254550 |
| Other Study ID Numbers: |
Swazi PrEP study |
| First Posted: | August 18, 2017 Key Record Dates |
| Last Update Posted: | July 11, 2019 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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PrEP |
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |