Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02702895
Other study ID # MTN-032
Secondary ID UM1AI068633UM1AI
Status Completed
Phase
First received
Last updated
Start date June 13, 2016
Est. completion date December 19, 2019

Study information

Verified date June 2021
Source Microbicide Trials Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore socio-contextual and trial specific issues which affected participants' adherence to the dapivirine vaginal ring (VR), as well as male partner attitudes towards and experiences with the dapivirine VR and their perspective of their female partner's attitudes and experiences.


Description:

The MTN-032 trial is a two-phase exploratory sub-study of the ASPIRE and HOPE trials. A total of 187 former ASPIRE participants aged 19-48 years were enrolled in Phase 1 of this study. Up to 156 HOPE participants and up to 120 male partners of HOPE participants will be selected for participation in Phase 2 of this study. There were approximately 4-6 months allotted for recruitment and follow-up at each site for Phase 1, and 9-12 months allotted for recruitment and follow-up at each site for Phase 2.. MTN-032, an observational study, using interviews and focus group discussions, is primarily designed to identify factors that may have affected participant adherence to study product in ASPIRE and HOPE, including male partner attitudes. MTN-032 will also elicit perceptions about various participant engagement and adherence promotion interventions implemented in ASPIRE and may also explore the potential use of incentives to promote adherence to VR use. MTN-032 will use study product adherence results from ASPIRE and HOPE, qualitative in-depth interviews (IDI) and focus group discussions (FGD) to explore study product adherence behaviors and strategies used to overcome adherence challenges. An in-depth understanding of the various socio-behavioral factors that contribute to product use adherence may assist in the interpretation of past and ongoing study results and inform implementation of future studies.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date December 19, 2019
Est. primary completion date December 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria (Phase 1 - Former ASPIRE participants): 1. Participated in the ASPIRE protocol, randomized to active product and informed of their randomization assignment. 2. Able and willing to provide written informed consent in one of the study languages. 3. Able and willing to complete the required study procedures. 4. For participants who did not acquire an HIV infection while taking part in ASPIRE, evidence of study product dispensation at a minimum of three consecutive ASPIRE scheduled clinic visits. For participants who acquired an HIV infection while taking part in ASPIRE, evidence of study product dispensation in the month prior to the participant's acquisition of HIV infection. 5. For participants who did not acquire an HIV infection while taking part in ASPIRE, have a minimum of three ASPIRE PK data measurement points available. For participants who acquired HIV infection while taking part in ASPIRE, have a minimum of one ASPIRE PK data measurement available. Inclusion Criteria (Phase 2 - HOPE participants): 1. Participated in the HOPE protocol. 2. Able and willing to provide written informed consent in one of the study languages. 3. Able and willing to complete the required study procedures. 4. For participants who did not acquire an HIV infection while taking part in HOPE, evidence of study product dispensation for a minimum of three consecutive months. 5. For participants who acquired an HIV infection while taking part in HOPE, evidence of study product dispensation in the month prior to the participant's acquisition of an HIV infection. Inclusion Criteria (Phase 2 - Male partners of HOPE participants): 1. Identifies as a male sexual partner of a HOPE participant for whom the HOPE participant has given permission to contact. 2. Was a male sexual partner of a HOPE participant during her participation in HOPE (regardless of whether she used the ring or not). 3. Able and willing to provide written informed consent in one of the study languages. 4. Able and willing to complete the required study procedures. 5. Is above the age of 18 at the time of study participation. Exclusion Criteria (Phase 1 and Phase 2): 1. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
In-depth Interview (IDIs) or Focus Group Discussion (FGD)


Locations

Country Name City State
Malawi Malawi Clinical Research Site Lilongwe
South Africa Botha's Hill Clinical Research Site Durban KwaZulu-Natal
South Africa CAPRISA eThekwini Clinical Research Site Durban KwaZulu-Natal
South Africa Wits Reproductive Health and HIV Institute Clinical Research Site Johannesburg
Uganda Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site Kampala
Zimbabwe Spilhaus Clinical Research Site Harare
Zimbabwe Zengeza Clinical Research Site Harare

Sponsors (4)

Lead Sponsor Collaborator
Microbicide Trials Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Malawi,  South Africa,  Uganda,  Zimbabwe, 

References & Publications (3)

Montgomery ET, Katz AWK, Duby Z, Mansoor LE, Morar NS, Naidoo K, Tsidya M, Chitukuta M, Guma V, Tenza S, Leslie J, Garcia M, Naidoo S. Men's Sexual Experiences with the Dapivirine Vaginal Ring in Malawi, South Africa, Uganda and Zimbabwe. AIDS Behav. 2021 — View Citation

Montgomery ET, Stadler J, Naidoo S, Katz AWK, Laborde N, Garcia M, Reddy K, Mansoor LE, Etima J, Zimba C, Chitukuta M, Soto-Torres L. Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS. 20 — View Citation

Naidoo K, Mansoor LE, Katz AWK, Garcia M, Kemigisha D, Morar NS, Zimba CC, Chitukuta M, Reddy K, Soto-Torres L, Naidoo S, Montgomery ET. Qualitative Perceptions of Dapivirine VR Adherence and Drug Level Feedback Following an Open-Label Extension Trial. J — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Factors affecting product use adherence Socio-contextual and trial specific issues which affected participants' adherence to the dapivirine VR will be captured by IDI and/or FGD. Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Primary Male partner attitudes affecting product use adherence male partner attitudes towards and experiences with the dapivirine VR, and their perspective of their female partner's attitudes and experienceswill be captured by FGD and/or IDI. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Secondary Perceptions of HIV risk HIV risk and perceptions of HIV risk in general and specific to participants' and their male partners' motivation to participate in the ASPIRE and/or HOPE trial(s), to use study product (or not) during their participation in ASPIRE and/or HOPE, and male partner support (or lack thereof) of participants' product use in HOPE will be captured by IDI and/or FGD. Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Secondary Product use patterns Factors influencing product initiation and patterns of use during ASPIRE and/or HOPE will be captured by IDI and/or FGD. Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Secondary Perceptions of various adherence support interventions Participants' perceptions of various adherence support interventions and engagement activities implemented (or not implemented) during ASPIRE and/or HOPE will be captured by IDI and/or FGD. Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Secondary Understanding of ASPIRE results and ring efficacy Participants' and their male partners' understanding of the ASPIRE results and ring efficacy, and the impact of this understanding on participants' intention and/or ability to join HOPE and continue in follow-up, on their adherence to the dapivirine VR as part of an open label extension trial as compared to adherence in a Phase 3 safety and effectiveness trial, and male partner support (or lack thereof) of participants' trial participation and product use in HOPE will be captured by IDI and/or FGD. Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
See also
  Status Clinical Trial Phase
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Active, not recruiting NCT03112369 - Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use N/A
Not yet recruiting NCT03642314 - HIV Self-testing in Implementation PrEP Study N/A
Completed NCT01810315 - Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity Phase 1
Completed NCT00984971 - Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet Phase 1
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Active, not recruiting NCT03255915 - PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study) Early Phase 1
Completed NCT05037513 - Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky N/A
Recruiting NCT05087680 - An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South N/A
Recruiting NCT05804461 - Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico N/A
Completed NCT03148171 - Project WERK (Wellness Encouragement Respect Kinship) N/A
Completed NCT04791007 - OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults Early Phase 1
Recruiting NCT05412433 - Clinic-based HIV Identification and Prevention Project Using Electronic Resources N/A
Active, not recruiting NCT03977181 - The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms N/A
Recruiting NCT05165745 - Stick2PrEP Cisgender Women and Trans Individuals N/A
Completed NCT03719053 - Single Dose Truvada Study Phase 1
Recruiting NCT03856580 - Long-acting Biomedical HIV Prevention in Transgender Women N/A
Completed NCT02750540 - Optimization of a Tenofovir Enema for HIV Prevention Phase 1
Completed NCT01386294 - Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection Phase 3
Completed NCT00993811 - The Shang Ring: A Novel Male Circumcision Device for HIV Prevention Phase 1