Trial Outcomes & Findings for Monoclonal Antibody-based Multipurpose Microbicides (NCT NCT01859195)

Last Updated: 2026-02-23

Results Overview

Frequency of product use during specified sex in the past 12 months. Response options: 0= None of the time; 1 = Some of the time, 2 = Half of the time, 3 = Most of the time; 4 = All of the time; 5 = Not applicable (did not have specified sex)

Recruitment status

COMPLETED

Target enrollment

36 participants

Primary outcome timeframe

1 year

Results posted on

2026-02-23

Participant Flow

Recruited May-Aug 2013 (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth. Volunteers complete prescreen survey. If eligible, each was invited to participate in research questionnaire assessing previous product use and sexual and reproductive history.

Participant milestones

Participant milestones
Measure	Female Participants Participants exploring thoughts, opinions, and ideas about vaginal products.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Monoclonal Antibody-based Multipurpose Microbicides

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Female Participants n=29 Participants Female research study participants who completed a demographics and sexual behavior questionnaire.
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=58 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=58 Participants
Age, Categorical <=18 years	0 Participants n=58 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=58 Participants
Age, Categorical >=65 years	0 Participants n=58 Participants
Sex: Female, Male Female	29 Participants n=58 Participants
Sex: Female, Male Male	0 Participants n=58 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=58 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=58 Participants
Race (NIH/OMB) Asian	0 Participants n=58 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants
Race (NIH/OMB) Black or African American	7 Participants n=58 Participants
Race (NIH/OMB) White	18 Participants n=58 Participants
Race (NIH/OMB) More than one race	3 Participants n=58 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=58 Participants
Region of Enrollment United States	29 Participants n=58 Participants
Current Marital Status Never Been Married	16 Participants n=58 Participants
Current Marital Status Married	9 Participants n=58 Participants
Current Marital Status Separated	1 Participants n=58 Participants
Current Marital Status Divorced	0 Participants n=58 Participants
Current Marital Status Widowed	2 Participants n=58 Participants
Current Marital Status Other: Engaged	1 Participants n=58 Participants
Yearly Income Less than $15,000	11 Participants n=58 Participants
Yearly Income $15,000 to $36,000	13 Participants n=58 Participants
Yearly Income More Than $36,000	4 Participants n=58 Participants
Yearly Income Refused To Answer	1 Participants n=58 Participants
Highest Education Level Some High School	2 Participants n=58 Participants
Highest Education Level High School Diploma or GED	7 Participants n=58 Participants
Highest Education Level Some College	9 Participants n=58 Participants
Highest Education Level Bachelor's Degree	10 Participants n=58 Participants
Highest Education Level Graduate or Professional Degree	1 Participants n=58 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Numbers analyzed for each scale may differ from overall sample as some items may not have been answered by a given participant.

Outcome measures

Outcome measures
Measure	Female Participants n=29 Participants Participants who completed demographics and sexual behavior questionnaire.
Frequency of Use How often used lubricant during VAGINAL sex in PAST 12 MONTHS?	1.14 units on a scale Standard Deviation 1.25
Frequency of Use How often used condom during VAGINAL sex in PAST 12 MONTHS?	1.31 units on a scale Standard Deviation 1.73
Frequency of Use How often used vaginal film during VAGINAL sex in PAST 12 MONTHS?	0.00 units on a scale Standard Deviation 0.00
Frequency of Use How often used diaphragm during VAGINAL sex in PAST 12 MONTHS?	0.00 units on a scale Standard Deviation 0.00
Frequency of Use How often used condom during ANAL sex in PAST 12 MONTHS?	3.62 units on a scale Standard Deviation 2.27
Frequency of Use How often used condom Giving ORAL sex in PAST 12 MONTHS?	1.00 units on a scale Standard Deviation 2.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Number of participants who ever engaged in specified behavior.

Outcome measures

Outcome measures
Measure	Female Participants n=29 Participants Participants who completed demographics and sexual behavior questionnaire.
EVER Engaged in Behavior Vaginal Medication EVER Used	20 Participants
EVER Engaged in Behavior Vaginal Douche EVER Used	12 Participants
EVER Engaged in Behavior Vaginal Lubricants EVER Used	26 Participants
EVER Engaged in Behavior Spermicides EVER Used	8 Participants
EVER Engaged in Behavior Vaginal Films EVER Used	4 Participants
EVER Engaged in Behavior Intravaginal Ring EVER Used	3 Participants
EVER Engaged in Behavior Cervical Caps EVER Used	0 Participants
EVER Engaged in Behavior Diaphragms EVER Used	1 Participants
EVER Engaged in Behavior Tampons EVER Used	22 Participants
EVER Engaged in Behavior Menstrual Cups EVER Used	2 Participants
EVER Engaged in Behavior EVER had sex to get money, or other needs, like food or a place to sleep or stay?	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Number of participants currently using specified product.

Outcome measures

Outcome measures
Measure	Female Participants n=29 Participants Participants who completed demographics and sexual behavior questionnaire.
Product Use CURRENT Male Condom CURRENT Use	11 Participants
Product Use CURRENT Female Condom CURRENT Use	1 Participants
Product Use CURRENT Non-Hormonal IUD CURRENT Use	0 Participants
Product Use CURRENT Rhythm Method CURRENT Use	1 Participants
Product Use CURRENT Partner Vasectomy	1 Participants
Product Use CURRENT No CURRENT Contraceptive Use	1 Participants
Product Use CURRENT Hormonal Contraceptive CURRENT Use	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Numbers analyzed for each item may differ from overall sample as some items may not have been answered by a given participant.

Number of times participant engaged in specified sex in the past 12 months.

Outcome measures

Outcome measures
Measure	Female Participants n=29 Participants Participants who completed demographics and sexual behavior questionnaire.
Count (Number of Times) of Sexual Behavior How many times ANY kind of sex in past 12 MONTHS?	214.83 Number of times Standard Deviation 280.76
Count (Number of Times) of Sexual Behavior How many times VAGINAL sex in past 12 MONTHS?	131.79 Number of times Standard Deviation 183.82
Count (Number of Times) of Sexual Behavior How many times ANAL sex in past 12 MONTHS?	27.83 Number of times Standard Deviation 135.38
Count (Number of Times) of Sexual Behavior How many times Gave ORAL sex in past 12 MONTHS?	78.31 Number of times Standard Deviation 122.44

Adverse Events

Female Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

The Miriam Hospital

Phone: 401-793-4775 or 401-793-8180

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place